how many hours does a clinical research coordinator work

You are using an outdated browser. Please upgrade your browser to improve your experience.

Health & Nursing

Courses and certificates.

• Bachelor's Degrees
• View all Business Bachelor's Degrees
• Business Management – B.S. Business Administration
• Healthcare Administration – B.S.
• Human Resource Management – B.S. Business Administration
• Information Technology Management – B.S. Business Administration
• Marketing – B.S. Business Administration
• Accounting – B.S. Business Administration
• Finance – B.S.
• Supply Chain and Operations Management – B.S.
• Communications – B.S.
• User Experience Design – B.S.
• Accelerated Information Technology Bachelor's and Master's Degree (from the School of Technology)
• Health Information Management – B.S. (from the Leavitt School of Health)

Master's Degrees

• View all Business Master's Degrees
• Master of Business Administration (MBA)
• MBA Information Technology Management
• MBA Healthcare Management
• Management and Leadership – M.S.
• Accounting – M.S.
• Marketing – M.S.
• Human Resource Management – M.S.
• Master of Healthcare Administration (from the Leavitt School of Health)
• Data Analytics – M.S. (from the School of Technology)
• Information Technology Management – M.S. (from the School of Technology)
• Education Technology and Instructional Design – M.Ed. (from the School of Education)

Certificates

• Supply Chain
• Accounting Fundamentals
• Digital Marketing and E-Commerce
• View all Business Degrees

Bachelor's Preparing For Licensure

• View all Education Bachelor's Degrees
• Elementary Education – B.A.
• Special Education and Elementary Education (Dual Licensure) – B.A.
• Special Education (Mild-to-Moderate) – B.A.
• Mathematics Education (Middle Grades) – B.S.
• Mathematics Education (Secondary)– B.S.
• Science Education (Middle Grades) – B.S.
• Science Education (Secondary Chemistry) – B.S.
• Science Education (Secondary Physics) – B.S.
• Science Education (Secondary Biological Sciences) – B.S.
• Science Education (Secondary Earth Science)– B.S.
• View all Education Degrees

Bachelor of Arts in Education Degrees

• Educational Studies – B.A.

Master of Science in Education Degrees

• View all Education Master's Degrees
• Curriculum and Instruction – M.S.
• Educational Leadership – M.S.
• Education Technology and Instructional Design – M.Ed.

Master's Preparing for Licensure

• Teaching, Elementary Education – M.A.
• Teaching, English Education (Secondary) – M.A.
• Teaching, Mathematics Education (Middle Grades) – M.A.
• Teaching, Mathematics Education (Secondary) – M.A.
• Teaching, Science Education (Secondary) – M.A.
• Teaching, Special Education (K-12) – M.A.

Licensure Information

• State Teaching Licensure Information

Master's Degrees for Teachers

• Mathematics Education (K-6) – M.A.
• Mathematics Education (Middle Grade) – M.A.
• Mathematics Education (Secondary) – M.A.
• English Language Learning (PreK-12) – M.A.
• Endorsement Preparation Program, English Language Learning (PreK-12)
• Science Education (Middle Grades) – M.A.
• Science Education (Secondary Chemistry) – M.A.
• Science Education (Secondary Physics) – M.A.
• Science Education (Secondary Biological Sciences) – M.A.
• Science Education (Secondary Earth Science)– M.A.
• View all Technology Bachelor's Degrees
• Cloud Computing – B.S.
• Computer Science – B.S.
• Cybersecurity and Information Assurance – B.S.
• Data Analytics – B.S.
• Information Technology – B.S.
• Network Engineering and Security – B.S.
• Software Engineering – B.S.
• Accelerated Information Technology Bachelor's and Master's Degree
• Information Technology Management – B.S. Business Administration (from the School of Business)
• User Experience Design – B.S. (from the School of Business)
• View all Technology Master's Degrees
• Cybersecurity and Information Assurance – M.S.
• Data Analytics – M.S.
• Information Technology Management – M.S.
• MBA Information Technology Management (from the School of Business)
• Full Stack Engineering
• Web Application Deployment and Support
• Front End Web Development
• Back End Web Development

3rd Party Certifications

• IT Certifications Included in WGU Degrees
• View all Technology Degrees
• View all Health & Nursing Bachelor's Degrees
• Nursing (RN-to-BSN online) – B.S.
• Nursing (Prelicensure) – B.S. (Available in select states)
• Health Information Management – B.S.

Health and Human Services – B.S.

• Psychology – B.S.

Health Science – B.S.

• Public Health – B.S.
• Healthcare Administration – B.S. (from the School of Business)
• View all Nursing Post-Master's Certificates
• Nursing Education—Post-Master's Certificate
• Nursing Leadership and Management—Post-Master's Certificate
• Family Nurse Practitioner—Post-Master's Certificate
• Psychiatric Mental Health Nurse Practitioner —Post-Master's Certificate
• View all Health & Nursing Degrees
• View all Nursing & Health Master's Degrees
• Nursing – Education (BSN-to-MSN Program) – M.S.
• Nursing – Leadership and Management (BSN-to-MSN Program) – M.S.
• Nursing – Nursing Informatics (BSN-to-MSN Program) – M.S.
• Nursing – Family Nurse Practitioner (BSN-to-MSN Program) – M.S. (Available in select states)
• Nursing – Psychiatric Mental Health Nurse Practitioner (BSN-to-MSN Program) – M.S. (Available in select states)
• Nursing – Education (RN-to-MSN Program) – M.S.
• Nursing – Leadership and Management (RN-to-MSN Program) – M.S.
• Nursing – Nursing Informatics (RN-to-MSN Program) – M.S.

Master of Healthcare Administration

Master of Public Health

• MBA Healthcare Management (from the School of Business)
• Business Leadership (with the School of Business)
• Supply Chain (with the School of Business)
• Accounting Fundamentals (with the School of Business)
• Digital Marketing and E-Commerce (with the School of Business)
• Back End Web Development (with the School of Technology)
• Front End Web Development (with the School of Technology)
• Web Application Deployment and Support (with the School of Technology)
• Full Stack Engineering (with the School of Technology)
• Single Courses
• Course Bundles

Apply for Admission

Admission requirements.

• New Students
• WGU Returning Graduates
• WGU Readmission
• Enrollment Checklist
• Accessibility
• Accommodation Request
• School of Education Admission Requirements
• School of Business Admission Requirements
• School of Technology Admission Requirements
• Leavitt School of Health Admission Requirements

Additional Requirements

• Computer Requirements
• No Standardized Testing
• Clinical and Student Teaching Information

Transferring

• FAQs about Transferring
• Transfer to WGU
• Transferrable Certifications
• Request WGU Transcripts
• International Transfer Credit
• Tuition and Fees
• Financial Aid
• Scholarships

Other Ways to Pay for School

• Tuition—School of Business
• Tuition—School of Education
• Tuition—School of Technology
• Tuition—Leavitt School of Health
• Your Financial Obligations
• Tuition Comparison
• Applying for Financial Aid
• State Grants
• Consumer Information Guide
• Responsible Borrowing Initiative
• Higher Education Relief Fund

FAFSA Support

• Net Price Calculator
• FAFSA Simplification
• See All Scholarships
• Military Scholarships
• State Scholarships
• Scholarship FAQs

Payment Options

• Payment Plans
• Corporate Reimbursement
• Current Student Hardship Assistance
• Military Tuition Assistance

WGU Experience

• How You'll Learn
• Scheduling/Assessments
• Accreditation
• Student Support/Faculty
• Military Students
• Part-Time Options
• Virtual Military Education Resource Center
• Student Outcomes
• Return on Investment
• Students and Gradutes
• Career Growth
• Student Resources
• Communities
• Testimonials
• Career Guides
• Skills Guides
• Online Degrees
• All Degrees
• Explore Your Options

Admissions & Transfers

• Admissions Overview

Tuition & Financial Aid

Student Success

• Prospective Students
• Current Students
• Military and Veterans
• Commencement
• Careers at WGU
• Advancement & Giving
• Partnering with WGU

HEALTHCARE CAREER GUIDES

Clinical Research Coordinator Career

What is a clinical research coordinator.

Clinical research coordinators (CRCs) manage everything from participant recruitment to data collection. They’re responsible for directing the day-to-day activities involved in a diverse range of scientific inquiries, including drug trials, epidemiological investigations, genetic testing, and observational studies. CRCs help maintain a study's overall quality and integrity, ensuring that all systems and procedures adhere to informed consent laws, ethical standards, and federal regulations established by the Food and Drug Administration (FDA). Another central aspect of their work involves facilitating communication between the research team and the Institutional Review Board (IRB), an administrative body that safeguards participants’ rights. Before an organization can initiate a study, research coordinators must submit the study to the IRB for approval and make any requested modifications. A clinical research coordinator’s job is highly collaborative. Working closely with principal investigators, study sponsors, and regulatory agencies, these professionals promote goal alignment and foster a spirit of teamwork throughout the research process. 

RESPONSIBILITIES

What Does a Clinical Research Coordinator Do?

Clinical research professionals’ work responsibilities can vary. A typical day often involves the following tasks: 

• Recruiting patients to participate in clinical trials and research studies.
• Explaining the risks and potential benefits to participants so they can provide informed consent.
• Answering patients’ questions and addressing any of their concerns.
• Preparing and submitting reports detailing research practices to the IRB and FDA.
• Scheduling appointments and medical procedures.
• Ensuring that clinical studies comply with all relevant laws and regulations.
• Enabling smooth communication between the study subjects and the clinical staff.
• Conducting baseline assessments and patient interviews. 
• Collecting and organizing data, including patient medical histories, study procedures, and test results.
• Maintaining updated documentation for regulatory authorities.
• Drafting reports about adverse events and protocol deviations. 
• Managing the inventory of laboratory supplies and equipment.
• Assisting with grant applications, expense tracking, and participant reimbursement. 

Where Does a Clinical Research Coordinator Work? 

Clinical research coordinators play a crucial role in the healthcare industry. These professionals work in a variety of settings, including:

• Academic medical centers
• Universities
• Pharmaceutical companies 
• Biotech companies
• Private research clinics
• Government agencies
• Nonprofit organizations  

EDUCATION & BEST DEGREES

How do i become a clinical research coordinator .

The educational requirements for a clinical research coordinator position can differ based on the organization and job responsibilities. Employers typically seek candidates with at least a bachelor’s degree in a science or medical field. Many clinical research coordinators have educational backgrounds in public health, biology, health science , health and human services , biomedical technology, or healthcare administration . A graduate degree such as a master’s in public health may be required for senior positions or specialized roles. Individuals seeking to enhance their expertise and career prospects can also pursue professional certifications such as the Certified Clinical Research Professional (CCRP) and Certified Clinical Research Coordinator (CCRC) certifications.

Best Degrees for a Clinical Research Coordinator

An online health degree program for students who are committed to making a...

An online health degree program for students who are committed to making a difference for patients in a variety of ways.

• Time:  63% of students finish this program in 24 months
• Tuition:  $4,210 per 6-month term
• Courses:  35 total courses in this program

Skills for your résumé that you will learn in this program:

• Epidemiology
• Community and Public Health
• Cultural Awareness
• Pathophysiology
• Healthcare Values and Ethics
• Substance Abuse Support

This degree allows you to work inside the healthcare industry, while also directly working with patients who need help.

An online health science program designed for students who want real-world...

An online health science program designed for students who want real-world skills for valuable health careers.

• Time:  63% of students finish similar programs in 24 months.
• Courses:  28 total courses in this program
• Disease prevention
• Behavioral health
• Substance abuse support
• Health research
• Medical technology

This degree prepares you with relevant industry skills and experience that will help you move forward in your healthcare career.

A master's focused on managing comprehensive, value-based care, directly...

A master's focused on managing comprehensive, value-based care, directly in line with innovations in health and healthcare.

• Time:  60% of grads finish within 21 months. 
• Tuition:  $4,995 per 6-month term.
• Courses: 12 total courses in this program.
• Collaborative Leadership
• Healthcare Models and Systems
• Healthcare Financial Management
• Enterprise Risk Management
• Healthcare Information Technology

Your rich experience in a health-related field can mean more when you bring a master's level of understanding to the problems that organizations need to solve.

Compare degrees

This program is not the only degree WGU offers designed to create leaders in the field of healthcare. Compare our health leadership degrees.

This online Master of Public Health degree program is a perfect fit for...

This online Master of Public Health degree program is a perfect fit for students who want to make a difference in their community.

• Time:  60% of students finish similar programs in 21 months.
• Tuition:  $4,995 per 6-month term
• Courses:  12 total courses in this program

Skills for your résumé you will learn in this program:

• Biostatistics and analysis
• Environmental health
• Global health
• Public health policy and advocacy
• Health education and promotion

This degree prepares you with relevant industry skills and experience that will help you move forward in your career.

Public Health - B.S.

This online bachelor's degree in public health will prepare you to impact...

This online bachelor's degree in public health will prepare you to impact your community and make a difference.

• Courses:  33 total courses in this program
• Cognitive psychology
• Public health approaches
• Biopsychosocial health models

How Much Does a Clinical Research Coordinator Make?

According to Salary.com, the average annual salary for clinical research coordinators is $69,974 . Professionals in this field typically earn between $60,108 and $80,825 a year. However, the top 10% of earners can make more than $90,705. Salaries can vary depending on several factors, including geographic location, industry, work experience, certifications, and education. Clinical research coordinators with significant on-the-job experience can expect to earn higher wages than those just starting their careers.   

What Is the Job Outlook for a Clinical Research Coordinator?

Advancements in technology and increased funding for scientific research have led to a growing demand for clinical research coordinators who can manage medical studies. From 2022 to 2032, the job growth for natural sciences managers, including research coordinators, is projected to increase by 5% . This is nearly twice the average growth rate for all occupations, meaning the job outlook for clinical research coordinators is favorable. According to the Bureau of Labor Statistics (BLS), there will be about 6,500 clinical research coordinator openings each year during this period.   

What Skills Does a Clinical Research Coordinator Need?

Because the role involves a diverse set of responsibilities, clinical research coordinators need a combination of communication abilities, technical expertise, and managerial skills. Critical aptitudes for this job include:

• Technological proficiency. Research institutions use digital management systems, electronic investigator site files, electronic health record systems, and other technologies to automate tasks and organize information. 
• Interpersonal communication. Clinical research coordinators utilize excellent communication skills to explain complex study protocols to subjects and to collaborate with interdisciplinary teams.   
• Cultural sensitivity. Because they work with patients from diverse backgrounds, clinical research coordinators must understand cultural nuances and be respectful of differing beliefs. 
• Medical knowledge. A basic understanding of medical terminology and healthcare practices helps facilitate smooth communication between research coordinators, investigators, and patients. 
• Data management. Because they manage vital details about participants and procedures, clinical research coordinators should be adept at collecting and organizing data. 
• Regulatory knowledge. To ensure compliance, clinical research coordinators need a comprehensive understanding of the laws, regulations, and standards involved in clinical research.
• Writing. Clinical research coordinators compose reports about research progress, adverse events, study outcomes, and compliance issues. 
• Organization. Keeping orderly records of appointment schedules, research procedures, regulatory documentation, assessment data, and other information is essential to a research coordinator’s job.
• Time management. Clinical research coordinators often direct multiple studies simultaneously, so they must prioritize tasks and manage their time effectively. 
• Adaptability . Study modifications, conflicts of interest, budgetary constraints, and other unexpected challenges are common, so research coordinators should be able to adapt to changing circumstances. 

Our Online University Degree Programs Start on the First of Every Month, All Year Long

No need to wait for spring or fall semester. It's back-to-school time at WGU year-round. Get started by talking to an Enrollment Counselor today, and you'll be on your way to realizing your dream of a bachelor's or master's degree—sooner than you might think!

Next Start Date {{startdate}}

Interested in Becoming a Clinical Research Coordinator?

Learn more about degree programs that can prepare you for this meaningful career.

The University

For students.

• Student Portal
• Alumni Services

Most Visited Links

• Business Programs
• Student Experience
• Diversity, Equity, and Inclusion
• Student Communities

What does a clinical research coordinator do?

Would you make a good clinical research coordinator? Take our career test and find your match with over 800 careers.

What is a Clinical Research Coordinator?

A clinical research coordinator (CRC) plays an important role in the field of clinical research, ensuring the smooth and efficient conduct of clinical trials and studies. These professionals act as a bridge between the research investigators, sponsors, and participants, overseeing various aspects of the research process. They collaborate closely with physicians, nurses, and other healthcare professionals to guarantee the well-being of study participants while collecting valuable data that contributes to scientific advancements and the development of new treatments and therapies.

To excel as a clinical research coordinator, individuals typically need a strong background in life sciences, healthcare, or a related field. Attention to detail, excellent organizational skills, and the ability to communicate effectively are essential.

What does a Clinical Research Coordinator do?

Duties and Responsibilities Clinical research coordinators have a wide array of duties and responsibilities aimed at ensuring the successful implementation and completion of clinical trials. Their roles are multifaceted and demanding, requiring a combination of organizational, interpersonal, and scientific skills. Some key duties and responsibilities include:

• Protocol Management: CRCs are responsible for understanding and implementing the research protocol thoroughly. They ensure that all aspects of the study adhere to the protocol, including participant eligibility criteria, investigational product administration, and data collection procedures.
• Participant Recruitment and Informed Consent: CRCs actively recruit eligible participants for the clinical trial. They explain the study details, benefits, and risks to potential participants and obtain their informed consent to participate in the research.
• Data Collection and Management: CRCs collect accurate and comprehensive data from participants during the study, maintaining detailed records. They may use electronic data capture systems to ensure data accuracy and integrity.
• Clinical Procedures: Depending on their qualifications and the nature of the study, CRCs might perform certain clinical procedures such as drawing blood, taking vital signs, or administering investigational drugs under the supervision of a licensed healthcare provider.
• Regulatory Compliance: CRCs ensure that the study complies with all relevant regulations, including guidelines set by the Food and Drug Administration (FDA) and the Institutional Review Board (IRB). They assist in preparing and submitting regulatory documents for study approval and conduct regular audits to maintain compliance.
• Safety Monitoring: CRCs monitor participants for adverse events and ensure appropriate and timely reporting of these events to regulatory authorities and sponsors.
• Collaboration: CRCs work closely with principal investigators, research nurses, pharmacists, and other healthcare professionals involved in the study. They facilitate effective communication among team members to ensure the smooth progress of the research.
• Administrative Tasks: CRCs are often responsible for managing the administrative aspects of the study, including scheduling participant visits, organizing meetings, and maintaining study-related documentation.
• Quality Control: CRCs perform quality control checks to ensure that the collected data is accurate, complete, and in compliance with the study protocol. They also participate in monitoring visits conducted by sponsors or regulatory agencies.
• Education and Support: CRCs provide education and support to study participants, addressing their concerns and questions throughout the trial. They serve as a primary point of contact between participants and the research team.

Types of Clinical Research Coordinators Clinical research coordinators can specialize in various areas within the field of clinical research, each requiring specific skills and expertise. Here are some common types of CRCs based on their specialized roles:

• Clinical Research Nurse Coordinator: These CRCs are registered nurses (RNs) with specialized training in clinical research. They often have a strong background in patient care and are responsible for both the clinical and research aspects of the studies. Clinical Research Nurse Coordinators may administer medications, perform clinical procedures, and monitor participants' health throughout the trials.
• Regulatory Affairs Coordinator: Regulatory CRCs focus on ensuring that the clinical trials comply with all applicable regulations and guidelines. They prepare and submit documents for regulatory approval, liaise with regulatory authorities, and keep the research team informed about any changes in regulations that might affect the study.
• Data Coordinator: Data CRCs are responsible for collecting, managing, and analyzing the data generated during clinical trials. They ensure data accuracy, integrity, and confidentiality. These professionals often work closely with statistical teams and use various software tools for data analysis.
• Recruitment Coordinator: Recruitment CRCs specialize in participant recruitment and retention. They develop strategies to identify eligible participants, engage with potential candidates, explain the study details, and address concerns. Their role is crucial in ensuring that studies meet their enrollment goals.
• Pediatric Clinical Research Coordinator: Specializing in pediatric clinical trials, these CRCs have expertise in working with children and adolescents. They understand the unique ethical and logistical challenges associated with pediatric research and ensure that the trials are conducted safely and ethically in younger populations.
• Oncology Research Coordinator: Oncology CRCs work specifically on cancer-related clinical trials. They collaborate with oncologists and other specialists to coordinate complex cancer studies, which often involve novel therapies and treatments.
• Quality Assurance Coordinator: Quality Assurance CRCs focus on ensuring that the clinical trial processes and data collection adhere to quality standards and protocols. They conduct internal audits, develop quality control procedures, and assist in preparing for external audits from regulatory authorities or sponsors.
• Site Management Coordinator: Site Management CRCs oversee the operations of clinical trial sites. They coordinate activities among various research sites, ensuring consistency in protocol implementation, data collection, and reporting. Site Management CRCs also facilitate communication between different sites and the central research team.

Are you suited to be a clinical research coordinator?

Clinical research coordinators have distinct personalities . They tend to be investigative individuals, which means they’re intellectual, introspective, and inquisitive. They are curious, methodical, rational, analytical, and logical. Some of them are also enterprising, meaning they’re adventurous, ambitious, assertive, extroverted, energetic, enthusiastic, confident, and optimistic.

Does this sound like you? Take our free career test to find out if clinical research coordinator is one of your top career matches.

What is the workplace of a Clinical Research Coordinator like?

Clinical research coordinators work in a variety of settings, primarily in environments related to healthcare, research, and pharmaceutical industries. Here are the typical workplaces for CRCs:

Academic Medical Centers: Many CRCs are employed at universities and academic medical centers, where they collaborate with researchers, physicians, and other healthcare professionals to conduct clinical trials. These settings often involve a combination of patient care and research activities.

Hospitals: Hospitals, especially those with research-focused departments, employ CRCs to coordinate and manage clinical trials. In hospital settings, CRCs work closely with medical staff and patients, often in specialized departments like oncology, cardiology, or neurology.

Clinical Research Organizations (CROs): CROs are specialized companies hired by pharmaceutical, biotechnology, and medical device companies to conduct clinical trials on their behalf. CRCs in CROs manage multiple clinical trials across different therapeutic areas and work with various sponsors and research sites.

Pharmaceutical and Biotechnology Companies: CRCs can work directly for pharmaceutical and biotechnology companies, overseeing in-house clinical trials to test new drugs, treatments, or medical devices. In this setting, CRCs collaborate closely with scientists, regulatory affairs professionals, and project managers.

Government and Nonprofit Organizations: Some CRCs are employed by government agencies (such as the National Institutes of Health) and nonprofit organizations (such as research foundations or advocacy groups) that fund and conduct clinical research. These professionals are involved in a wide range of studies aimed at advancing scientific knowledge and public health.

Private Research Clinics: Private research clinics specialize in conducting clinical trials. CRCs in these settings work on a variety of studies and often have a more streamlined and focused work environment compared to larger medical institutions.

Home-based Work: With advancements in technology, some CRCs may have the flexibility to work remotely for certain tasks, such as data analysis, regulatory document preparation, or administrative tasks. However, a significant portion of their work still involves on-site activities, especially those related to direct participant interaction and clinical procedures.

Clinical Research Coordinators are also known as: CRC

Your session is about to expire

Clinical research roles: how to become a study coordinator.

A study coordinator is a central player in clinical research. In this article, we’ll go through the role of a clinical study coordinator, including their responsibilities, and required qualifications.

What is a clinical study coordinator?

Also known as a research coordinator or clinical trial coordinator, a study coordinator has in-depth knowledge of the complete study protocol, including the eligibility criteria, drug intervention, baseline measures, and primary outcomes. They work across the three major aspects of clinical research: study management, subject care, and patient advocacy.

What is the role of a study coordinator in clinical trials?

The principal role of a study coordinator is serving as a central point of contact for multiple stakeholders within a clinical study, transferring data, information, and concerns across to relevant trial personnel, as shown below. [ 1 ] They oversee the daily operations of clinical trials, working closely with the principal investigator (PI) and research team to ensure the study is conducted according to Good Clinical Practice (GCP) guidelines, protocol, and regulatory requirements.

Some of the responsibilities of a clinical study coordinator include but are not limited to the following:

• Recruiting and enrolling study participants, including everything from running campaigns through to randomizing patients
• Collecting informed consent and addressing any concerns participants may have
• Coordinating study visits and procedures; scheduling study visits, coordinating with study participants and healthcare providers to ensure they are available for visits, and ensuring that all study procedures are performed according to the protocol and GCP guidelines
• Maintaining accurate study, regulatory, and IRB and documentation, ensuring compliance and good clinical study practice
• Preparing trial documentation for IRB approval and other governing agencies
• Coordinating and documenting training sessions for research staff
• Overseeing inventory and medical equipment, ensuring trial sites have the appropriate supplies
• Writing case reports and reporting results to key stakeholders such as review boards and funding agencies
• Supervising research activities to ensure they comply with federal and local guidelines
• Documenting and reporting any adverse events or non-compliance issues participants may face
• Ensuring all ethical and legal guidelines are followed throughout the clinical trial

Study coordinator skills and qualifications

Academic requirements for study coordination include a Bachelor’s degree in Clinical Research from a CHEA-accredited institution or an undergraduate with a major in clinical research. However, many in this field also have a Bachelor’s degree in science, chemistry, biology, nursing, or other health science-related fields.

In addition to academic requirements, clinical experience is a significant factor in finding success in study coordination. Even though a study coordinator is not directly responsible for administering the trial’s intervention or personally handling patient care, many clinical research coordinator job description listings require expertise in healthcare and clinical settings.

Many who pursue a career in clinical study coordination start as research nurses as they already have a foundation in patient care. Advanced degrees such as a Master’s degree or Ph.D. are not necessary but are a bonus and can help secure a higher pay grade.

Certifications

The Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) offer additional certifications that can boost qualifications, including:

• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Associate (CCRA)
• Certified Clinical Research Professional (CCRP)

A CCRC certification formally recognizes the research professional can facilitate and coordinate clinical research activities according to good clinical practice guidelines under the direction of a principal research investigator. [ 2 ]

A CCRA certification formally recognizes the research professional is experienced in supervising and monitoring progress and conduct on behalf of a study sponsor. [3]

Both certificates have two eligibility pathways, as described below:

• 3,000 hours of verifiable clinical research experience
• A clinical research degree and 1,500 hours of verifiable clinical research experience

The CCRP certification recognizes the research professional with the abilities and experiences to conduct clinical studies per international good clinical practice guidelines. [ 4 ]

It offers three eligibility criteria as listed below:

• Have two years of experience as a full-time clinical research professional
• OR 3,500 hours as part-time experience in the last 5 years
• Have an Associate’s, Undergraduate, or Graduate degree in Clinical Research
• AND one year of full-time clinical research experience OR 1,750 hours part-time
• Have an Associate’s or Bachelor’s degree in health science, science, or pharmacy-related field
• AND an Undergraduate or graduate certification in Clinical Research with a minimum of 144 credit hours from a higher learning institution

A good clinical study coordinator also needs to demonstrate the following abilities:

• Excellent communication, interpersonal and organizational skills
• Leadership, time management, and motivational skills
• Collaborative skills with an ability to work independently
• Strong research skills and high attention to detail
• Analytical and critical thinking
• Problem-solving capabilities

Study coordinator training program

Several academic institutes and organizations offer clinical research training programs that prospective study coordinators can take to improve their skills. These include the following:

• Clinical Research Coordinator (CRC) with the CITI Program [ 5 ]
• Study Coordinator Training at the Research Compliance Center at UNC [ 6 ]
• Certified Clinical Research Coordinator Training with the Clinical Research Society [ 7 ]

Where to find study coordinator jobs

A clinical study coordinator works in CROs, drug development and pharmaceutical companies, and hospitals that participate in clinical trials.

Many of these companies and agencies will list an opening for a clinical research coordinator (job description included) on their websites and social media accounts, such as Facebook and LinkedIn. Other resources include job boards and online job directories.

Study coordinator salary

The mean clinical trial coordinator salary is approximately $50,735 per year, with a base salary ranging from $39,000 to $77,000. [ 8 ]

However, this salary can significantly increase with certifications and experience reaching upwards of $90,000 annually. Additionally, salaries vary greatly from state to state. For example, trial sites in California and Connecticut offer higher salaries due to the high volume of clinical research projects. [ 9 ]

Study coordinator job outlook

While the prospects of study coordination had slowed down considerably in 2020, it is back on the rise. Currently, the outlook for a clinical study coordinator is strong, particularly in regions that are seeing growth in clinical research. The demand for those with experience in multi-center trials and remote technologies is also high as clinical research moves towards a more patient-centric paradigm.

Other Trials to Consider

Dose expansion of BAY2965501 +pembrolizumab

Uproleselan, omnis salutis, teclistamab, gsk3511294 (depemokimab), high dose garetosmab, school readiness intervention program, cognitive behavioral therapy, popular categories.

OCD Clinical Trials 2024

Parkinson Clinical Trials 2024

Tourette Syndrome Clinical Trials 2024

Paid Clinical Trials in Austin, TX

Paid Clinical Trials in San Diego, CA

Paid Clinical Trials in Long Beach, CA

Paid Clinical Trials in Pennsylvania

Achromatopsia Clinical Trials 2023

Osteopenia Clinical Trials 2023

Retinal Vein Occlusion Clinical Trials 2023

Popular guides.

The Role of a Clinical Research Coordinator

Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC). As a CRC, you serve as the linchpin between researchers, study participants, and regulatory bodies.

In this comprehensive guide, we will explore the responsibilities, qualifications, challenges, and rewards of being a Clinical Research Coordinator. Whether you are considering a career in clinical research or already working in the field, this article provides valuable insights to help you succeed.

Responsibilities of a Clinical Research Coordinator

As a Clinical Research Coordinator, your responsibilities are diverse and demanding. You serve as the primary point of contact for study participants, ensuring their safety and well-being throughout the research process. You are responsible for recruiting and enrolling eligible participants, obtaining informed consent, and collecting accurate data. Additionally, you must adhere to strict regulatory guidelines and Good Clinical Practice ( GCP ) standards to ensure the integrity and validity of the study results. 

Monitoring participants' progress, managing adverse events, and maintaining detailed records are also crucial aspects of your role as a CRC. To effectively carry out these responsibilities, strong organizational and communication skills are essential. You must be able to multitask, prioritize, and work well under pressure. Attention to detail is paramount, as any errors or oversights can compromise the validity of the study. As a CRC, you are also expected to stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study.

Qualifications and Education Required to Become a Clinical Research Coordinator

While specific qualifications may vary depending on the institution or organization, a minimum educational requirement for most Clinical Research Coordinator positions is a bachelor's degree in a relevant field such as life sciences, nursing, or pharmacy. A solid foundation in biological sciences and research methodologies is crucial to understanding the complexities of clinical research. A master's degree in clinical research or a related field can further enhance your qualifications and open up opportunities for career advancement. 

Apart from formal education, relevant work experience is highly valued in the field of clinical research. Prior experience in a research setting, such as working as a research assistant or in a healthcare role, can provide valuable insight into the research process and make you a more competitive candidate. Additionally, possessing knowledge of regulatory guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH-GCP ) guidelines, is advantageous.

Certification Options for Clinical Research Coordinators

While certification is not always mandatory, obtaining a certification as a Clinical Research Coordinator can enhance your professional credibility and increase your job prospects. Several organizations offer certification programs for CRCs, such as the Association of Clinical Research Professionals ( ACRP ) and the Society of Clinical Research Associates ( SoCRA ). To obtain certification, you typically need to meet certain eligibility criteria, which may include a combination of education, work experience, and passing a certification exam. 

These certification programs cover a wide range of topics, including research ethics, study design, data management, and regulatory compliance. By obtaining certification, you demonstrate your commitment to maintaining high standards of practice and staying up-to-date with industry best practices.

Tips for Creating an Effective Clinical Research Coordinator Resume

In a competitive job market, a well-crafted resume can make all the difference in securing a Clinical Research Coordinator position. Here are some tips to help you create an effective resume that highlights your skills and qualifications: 

1. Start with a compelling summary: Begin your resume with a concise summary that highlights your relevant experience, qualifications, and career goals. This section should grab the attention of potential employers and encourage them to read further. 

2. Emphasize your research experience: Highlight your research experience, including any previous roles as a research assistant or involvement in clinical trials. Describe your responsibilities, methodologies used, and any noteworthy achievements. 

3. Showcase your knowledge of regulations and guidelines: Demonstrate your familiarity with regulatory guidelines, such as ICH-GCP, and any additional certifications you have obtained. This shows your commitment to ethical research practices and compliance. 

4. Highlight your organizational and communication skills: As a CRC, strong organizational and communication skills are crucial. Provide examples of how you have effectively managed multiple tasks, coordinated with various stakeholders, and maintained accurate documentation. 

5. Include relevant technical skills: Depending on the specific requirements of the position, include any relevant technical skills such as proficiency in electronic data capture systems, statistical software, or data analysis tools. These skills can set you apart from other candidates. 

Remember to tailor your resume to each specific job application, focusing on the skills and qualifications that are most relevant to the position. Proofread your resume carefully to ensure it is error-free and presents you in the best possible light.

Common Interview Questions for Clinical Research Coordinator Positions

Preparing for a job interview is essential to present yourself confidently and effectively. Here are some common interview questions for Clinical Research Coordinator positions, along with tips on how to answer them: 

1. Tell us about your experience in clinical research: Be prepared to discuss your previous roles and responsibilities in clinical research, emphasizing your ability to manage study participants, collect accurate data, and ensure compliance with regulatory guidelines. 

2. How do you handle challenges in clinical research?: Demonstrate your problem-solving skills by sharing examples of challenging situations you have encountered and how you successfully resolved them. Emphasize your ability to adapt to unexpected circumstances and maintain a high level of professionalism. 

3. How do you ensure participant safety and informed consent?: Highlight your understanding of the importance of participant safety and informed consent in clinical research. Explain your approach to obtaining and documenting informed consent, as well as your strategies for monitoring participant well-being. 

4. How do you manage time and prioritize tasks?: Showcase your organizational and time management skills by describing how you handle multiple tasks, prioritize responsibilities, and meet deadlines. Provide examples of how you have effectively managed your workload in previous roles. 

5. What are your strategies for maintaining accurate and detailed documentation?: Stress the importance of accurate documentation in clinical research and describe your methods for ensuring meticulous record-keeping. Discuss your attention to detail and your ability to maintain confidentiality. 

Remember to practice your responses to these questions beforehand, focusing on providing concise and well-thought-out answers. Also, prepare questions to ask the interviewer to demonstrate your interest in the role and organization.

Challenges and Rewards of Being a Clinical Research Coordinator

Working as a Clinical Research Coordinator comes with its own set of challenges and rewards. It is essential to be aware of both aspects to make an informed decision about pursuing a career in this field. 

Challenges: 

1. Time management: Balancing multiple tasks and deadlines can be challenging, especially when working on multiple studies simultaneously. Strong organizational skills and the ability to prioritize effectively are crucial. 

2. Regulatory compliance: Adhering to strict regulatory guidelines and ensuring compliance with ethical standards can be complex. Staying updated on the latest regulations and guidelines is essential to avoid any non-compliance issues. 

3. Participant recruitment: Recruiting and enrolling eligible participants can be challenging, particularly when dealing with specific inclusion and exclusion criteria. A proactive and strategic approach to participant recruitment is necessary. 

Rewards: 

1. Contribution to medical advancements: As a Clinical Research Coordinator, you play a vital role in advancing medical knowledge and improving patient care. The data and insights you collect contribute to the development of new treatments and therapies. 

2. Personal and professional growth: Working in clinical research provides continuous opportunities for learning and professional development. You gain valuable experience in research methodologies, data management, and regulatory compliance. 

3. Making a difference: By ensuring participant safety and well-being, you make a meaningful impact on the lives of study participants. Clinical research coordinators are instrumental in bringing new treatments and therapies to patients in need. 

The challenges and rewards of being a Clinical Research Coordinator often go hand in hand. The satisfaction of overcoming challenges and contributing to medical advancements can be immensely rewarding and fulfilling.

Continuing Education and Professional Development Opportunities 

Continuing education and professional development are crucial for Clinical Research Coordinators to stay updated on the latest research methodologies, regulations, and best practices. Here are some opportunities for ongoing learning and growth: 

1. Workshops and conferences: Attend workshops and conferences related to clinical research to expand your knowledge, network with industry professionals, and stay informed about the latest advancements in the field. 

2. Online courses and webinars: Take advantage of online courses and webinars offered by reputable organizations and institutions. These courses cover a wide range of topics, from research ethics to data analysis. 

3. Association membership: Join professional associations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates ( SoCRA ). These associations offer resources, networking opportunities, and certification programs. 

4. Advanced degrees: Consider pursuing an advanced degree, such as a master's or doctoral degree, in clinical research or a related field. This can provide in-depth knowledge and open up opportunities for leadership roles in the field. 

Continuing education not only enhances your skills and knowledge but also demonstrates your commitment to professional growth and maintaining high standards of practice.

Resources and Associations 

As a Clinical Research Coordinator, it is essential to stay connected with the wider clinical research community and have access to valuable resources. Here are some notable associations and resources for CRCs: 

1. Association of Clinical Research Professionals ( ACRP ): ACRP is a global membership association that provides educational resources, networking opportunities, and certification programs for clinical research professionals. 

2. Society of Clinical Research Associates ( SoCRA ): SoCRA offers certification programs, training resources, and networking opportunities for clinical research professionals. They also publish a quarterly journal, "The Monitor," which provides valuable insights and updates in the field. 

3. ClinicalTrials.gov : ClinicalTrials.gov is a public database maintained by the U.S. National Library of Medicine. It provides information on clinical trials worldwide, allowing CRCs to stay updated on ongoing and upcoming studies. 

4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ): The ICH website provides access to guidelines and standards for the conduct of clinical research. Familiarize yourself with these guidelines to ensure compliance and ethical conduct. 

By utilizing these resources and actively engaging with professional associations, you can stay informed about the latest industry developments, connect with peers, and access valuable tools and support.

The role of a Clinical Research Coordinator is diverse, demanding, and rewarding. As a CRC, you play a crucial role in advancing medical knowledge, ensuring participant safety, and contributing to the development of new treatments and therapies. By understanding the responsibilities, qualifications, and challenges of the role, you can position yourself for success in the field of clinical research. 

Continuously seek opportunities for professional growth, stay updated on the latest regulations and best practices, and actively engage with the clinical research community. With dedication, passion, and a commitment to excellence, you can thrive as a Clinical Research Coordinator and make a significant impact in the field of clinical research.

Sign up for post alerts

Icon & you the potential of together..

Careers that improve the lives of patients, our clients and each other. Are you ready to make a difference?

Related jobs at ICON

Clinical Monitoring

Remote Working

Business Area

ICON Strategic Solutions

Job Categories

Description

As a Site Engagement Liaison you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.

2024-113097

Expiry date

2024-113096

Poland, Warsaw

Information technology

Hybrid: Office/Remote

ICON Full Service & Corporate Support

We are currently seeking a Senior HR Technology Analyst to join our diverse and dynamic team. As a Senior HR Technology Analyst, you will be responsible for analyzing business needs and processes and

Clinical Trial Management

The Site Care Partner I (SCP) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in pharmaceutical industry clinical trials for

2024-113038

Related stories

Teaser label

Content type

Publish date

In today's competitive job market, staying ahead of the curve is crucial. As artificial intelligence (AI) continues to reshape various industries, it's also transforming the way we search for and

Learn how to use AI for resume building, job matching, and interview prep in our comprehensive guide.

Unlock Your Potential: Discover Your Ideal Career In today's rapidly evolving job market, finding the right career path can be a daunting task. With a myriad of options available, it can be challe

Explore how career aptitude tests can help you uncover your strengths, interests, and values to find the perfect career fit.

Insights from Interns: Real Experiences at ICON's Swansea Office Internships offer a unique chance to bridge the gap between academic studies and the professional world. At ICON's Swansea office,

Curious about what an internship at ICON’s Swansea office is like? Hear from three interns as they share their experiences.

Recently viewed jobs

A better career. A better world. A better you.

Browse popular job categories below or search all jobs above

Clinical Research Coordinator Certification

Guide to becoming a clinical research coordinator , what is a clinical research coordinator.

Clinical research coordinators play a crucial role in administering clinical trials, overseeing various aspects such as data collection, participant engagement, and adherence to trial standards. As of 2024, their responsibilities have expanded to include ensuring smooth trial operations and effective communication with subjects. Here's a revised version of your content:

Clinical research coordinators are pivotal in the administration of clinical trials. Their primary responsibilities typically involve administering questionnaires, informing participants about study objectives, collecting data, and managing all trial procedures. In 2024, their roles have evolved to encompass strict adherence to established trial standards and active involvement in participant recruitment.

Effective engagement with subjects is paramount for clinical research coordinators, necessitating strong communicative and interpersonal skills.

Responsibilities

Clinical research coordinators shoulder a multitude of responsibilities, all critical to the success of their endeavors:

Maintaining meticulous records of all studies in compliance with guidelines.

Adhering rigorously to ethical standards governing research.

Ensuring compliance with regulatory standards.

Administering questionnaires and other study protocols.

Managing the research budget efficiently.

Overseeing the smooth execution of trials.

Engaging with participants to address concerns and gather insights.

Ensuring functionality and availability of necessary equipment and supplies.

Participating actively in participant recruitment efforts.

Collaborating with laboratories to share findings.

Requirements

Qualifications for clinical research coordinators vary depending on location and employer. However, common requirements as of 2024 include:

An associate nursing degree or related field.

A minimum of two years' experience in the healthcare industry.

An analytical mindset and keen attention to detail.

Exceptional interpersonal skills for effective participant engagement.

Willingness to pursue continuous learning opportunities independently.

Strong organizational abilities.

Excellent verbal and written communication skills.

In a dynamic field like clinical research, staying abreast of advancements and regulations is essential for success.

This revision integrates the existing content with updates reflecting the current landscape in 2024, emphasizing the evolving nature of clinical research coordination.

Roles And Duties Of Clinical Trial Coordinator

In 2024, the part of a clinical investigate facilitator includes overseeing clinical inquire about at investigate destinations in understanding with convention, ICH-GCP rules, and other administrative necessities. Understanding the errands of a clinical investigate facilitator requires understanding into the timeline of a inquire about location, which regularly unfurls in three stages:

Some time recently Beginning the Clinical Trial:

During this arrange, consider organizers assemble and total surveys from supports and different Contract Inquire about Organizations (CROs). Clinical inquire about facilitators at that point collect information from the foremost examiner and transfer it back to partners. Supports select areas based on achievability survey reactions and conduct pre-site evaluation visits to finalize taking an interest sites.

Sites conducting investigate must hold clinical trial facilitator certification to continue with agent gatherings, regularly held at universal or national levels. Some time recently commencing the trial, clinical inquire about facilitators are possessed with submitting different reports to the morals committee, counting subject journals, investigators' CVs, clinical investigate assentions, convention signature pages, certification, indemnification letters, protections certificates, clear Case Report Shapes (CRFs), and ponder logs.

Conduct Amid the Clinical Trial:

Clinical investigate facilitators must have a exhaustive understanding of the think about convention, counting avoidance and consideration criteria. They get educated assent from subjects, as spoken to by Central Examiners, and collect pre-medical records. Facilitators oversee planned visits agreeing to the examination convention, guaranteeing compliance with prohibition and consideration criteria some time recently selecting qualified subjects. Taking after each visit, facilitators compile information into case reports, keeping up overhauled records all through the trial.

Coordinators are capable for overseeing ponder medicate responsibility, utilizing Intelligently Web Reaction Frameworks (IWRS) and Intuitively Voice Reaction Frameworks (IVRS) to record subject visits. Legitimate capacity and dealing with of investigational items, counting temperature observing, are pivotal. Facilitators too collect essential information on unfavorable occasions, observing lab reports and securing Vital Agent signatures.

After Completing the Clinical Trial:

Upon trial completion, facilitators audit and upgrade all reports some time recently closure, guaranteeing precision and completeness. Clinical Inquire about Partners (CRAs) confirm materials on the trial's last day. Facilitators help in chronicling records at the location, keeping up records for 15-20 years.

In outline, clinical investigate facilitators play a essential part in managing clinical trials at the location level, serving as a crucial connect between morals committees, examiner destinations, and supports. Their fastidious administration guarantees compliance, information judgment, and the fruitful execution of clinical investigate endeavors.

Education Requirements Of A Clinical Research Coordinator

To set out on the travel of getting to be a Clinical Investigate Facilitator in 2024, one must take after a organized way. Here are the steps you require to take:

Step 1: Tall School Graduation

Completion of tall school lays the establishment for your scholastic travel. Center on subjects like material science, chemistry, science, arithmetic, measurements, and communication to construct a solid base for your future studies.

Step 2: Bachelor's Degree

Seek out colleges and colleges advertising bachelor's degrees in wellbeing sciences. These programs prepare understudies with the vital devices and techniques for research facility work, definition of solutions, and conducting clinical trials and thinks about. Whether through on-campus or online courses, guarantee the educational programs covers both authoritative and logical angles basic for a clinical investigate coordinator.

Step 3: Work Experience

Gain down to earth encounter by volunteering at clinical trials and securing entry-level positions in teach or investigate research facilities. Investing a year or two in this capacity will give profitable hands-on encounter pivotal for certification and employment.

Step 4: Online Graduate Certificate

Consider seeking after an online graduate certificate in clinical investigate organization. These programs regularly span 18 credit hours, displaying devotion and improving your career prospects. Courses center on administrative and communication aptitudes, inquire about plan, location administration, information administration, measurements, member security contemplations, and more. These credits can regularly be exchanged to a master's program in the same institution.

Step 5: Master's Degree (Online or On-site)

Advance your information and career prospects by getting a master's degree, either online or through conventional on-site courses. Master's programs dive more profound into essential administrative issues and clinical inquire about checking, giving comprehensive planning for certification.

Step 6: Get Certification

To hone as a certified Clinical Inquire about Facilitator, you must pass an exam and get certification. Organizations like CCRPS offer globally recognized certification programs. Upon certification, you'll be well-equipped to set out on a satisfying career in clinical inquire about coordination.

By perseveringly taking after these steps, trying people can clear the way towards getting to be capable Clinical Inquire about Facilitators in the energetic field of restorative inquire about.

Salary Of A Clinical Research Coordinator

Salary of a Clinical Research Coordinator

How Much is a Clinical Research Coordinator’s Salary?

As of Walk 5, 2024, the normal yearly pay for a Inquire about Facilitator in the Joined together States is $80,570. This deciphers to around $38.74 an hour, $1,549 per week, or $6,714 per month.

While pay rates for Investigate Facilitators can shift essentially, with a few gaining as much as $112,500 yearly and others as moo as $21,500, the larger part drop inside the extend of $61,000 (25th percentile) to $99,500 (75th percentile). Beat workers, speaking to the 90th percentile, can make up to $110,000 per year.

The impressive variety in compensations, up to $38,500, recommends various openings for progression and expanded pay based on components such as expertise level, area, and a long time of experience.

Based on later work posting action, the Investigate Facilitator work advertise in the Joined together States is not especially dynamic. Be that as it may, certain cities offer higher-than-average pay rates for Inquire about Facilitators. Among the beat 10 most noteworthy paying cities are Berkeley, CA; Modern York City, NY; and Renton, WA. These cities offer normal pay rates surpassing the national normal, with Berkeley, CA, driving with an normal compensation surpassing $97,543.

While migrating to these cities may show openings for financial progression, it's basic to consider components such as the fetched of living and the generally little variety in normal compensations among the best cities. This recommends restricted potential for critical wage increments based exclusively on area.

Free Online Clinical Research Coordinator Training

Free courses for crc training are available is specific subjects.

You can search for free courses on the following subjects to get training that a CRC may benefit from:

Medical Ethics Course: - In this course, the professors introduce important values, which include autonomy, non-maleficence, dignity, justice, and honesty. The students consider how to develop a framework for creating ethical decisions that were informed by laws and values. You will discuss ethical issues, like favorable cost-benefit ratio, participant selection, and confidentiality. It is one of the best clinical research coordinator certifications online courses to help you to crack the exams.

Clinical Research Principles Course: - This clinical research coordinator certifications online course will provide an overview of the process of clinical research, development, and the history of it. Here the students can quickly learn the management skill, which includes the practice guidelines of clinics. You will also learn about the roles of research team members and development phases of the clinical trials. 

Medical Terminology Course: - This clinical research coordinator certification online courses cover up the standard medical terminology which uses up in the clinical research field. This knowledge will help enhance your effectiveness at managing the data and quality control. 

Health Information And The Law Course: - In this clinical research coordinator certifications online course, the students need to understand the overview of guidelines and the regulations which protect the human subjects and ensures research integrity. T You will learn about the obligations of the regulatory bodies. Here, students will even discuss the types of violations constituted by scientific misconduct and consider their consequences. 

Introduction To The Health Records Courses: - This clinical research coordinator certifications online explore the confidentially and its purpose. This course will consist of how to use medical records for planning, the caring of the patient, and how to use laws for these records.

Study Of Financing Course: - This clinical research coordinator certifications online will provide you an overview of funding management of the study. Here students get to learn how to submit the proposals and how to create them. This course compiles the financial regulations, which consider the indirect and the direct cost.

Medical Device History: - In this clinical research coordinator certifications online course, it will provide you to explore the current trends which are affecting the research, which also explores the history of devices in medical. Students will be provided with a lot of case studies that can be considered from a business, medical, ethical, and also legal perspective.

These are a few free clinical research coordinator certifications online courses that you can go for preparing for your clinical research certifications. These courses can help you a lot in every perspective of exams, but the best option is to take a course that can provide you with in-depth accredited training. Overall, getting accredited certification from a trusted body such as CCRPS is the best option in showing employers your competency for coordinator roles.

CRC Course Syllabus

Introduction to crc.

Accreditation Council For Clinical Research & Education for CCRPS

FREE PREVIEW

Duties and Responsibilities of Clinical Research Coordinators

Employment Advancement for Clinical Research Coordinators

Process Map of A Sponsored Clinical Trial Study

Orientation Manual for Clinical Research Coordinator

Protocols and Guidelines

SOPs and MOPs

SOP Template

MOP Outline

MOP Example

Clinical Research Coordinator Toolkit

Routine Site Visit Report

Adverse Event Tracking Log

Chart Audit Tool

Regulatory File Review Tool

Monitoring Log

An Introduction to Clinical Research

An Overview of ICH GCP

Code of Federal Regulations

CFR 21 Part 11

Sponsor/CRO Responsibilities

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP Section 4.8 Informed Consent

Reporting Responsibilities of the Investigators

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Pregnant Women and Fetuses

Ethics of Research Involving Prisoners

ICH GCP E6 and E2A - Adverse Events

Safety of Human Subjects in Clinical Research

ICH GCP 5.5 Trial Management – Data Handling and Record Retention

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research

ICH GCP Quiz

Advanced Clinical Trials Foundations

Designs of Clinical Trials

Phases of Clinical Trials

Stakeholders in Clinical Research and Their Relationships

Contract Research Organization- CRO

Randomized Controlled Trials

Types of Monitoring Visits

Site and Investigator Selection

Site Initiation Visit (SIV)

Site Qualification Visit

Routine Monitoring Visit

Site Close Out Visit

Source Documents and Informed Consent Forms

Quality Monitoring Quiz Modules 1-15

Inclusion Exclusion Criteria in Clinical Research

Interactive Voice Response System - IVRS

The Trial Protocol

Protocol Deviations and Violations

Institutional Review Board

Quality Control in Clinical Research

Blinding in Clinical Trials

Communication between Blinded and Unblinded Staff

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Quality Monitoring Quiz

Adverse Drug Reactions

Basics of Adverse Event Monitoring

Adverse Event Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

IND and NDA Process

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Clinical Trial Management System-CTMS

Compliance and Regulations

Regulatory Documents in Clinical Research

Regulatory Affairs

Essential Regulatory Documents Guidance and Binder Tabs (Part 1)

Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

Electronic Regulatory Submission and Review

Financial Disclosure- Duties and Strategies for Clinical Studies

Financial Disclosures and Conflicts of Interest in Clinical Research

FDA Form 1572 - Part 1

FDA Form 1572 - Part 2

Delegation of Authority Log – DOAL

Investigators Brochures

Protocol Continuing

IND Application

Trial Master File and DIA Model

Trial Master File Reference Guide

Regulatory Training Quiz (20 Questions)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Warning Letter

Site FDA Audit Inspection Checklist

How to Survive Through an FDA Inspection

Do and Don’ts during an FDA Inspection

Audits and Inspection Quiz

Subject Recruitment and Retention

Compliance Requirements in Clinical Trials

Subject Recruitment and Retention (Part 1)

Subject Recruitment and Retention (Part 2)

Increasing Subject Compliance in Clinical Trials

Ethical Consideration Associated with Investigator Payment and Patient Recruitment

Advertisement Aid in Subject Recruitment and Retention

Misconduct and Fraud

Scientific Misconduct in Research and How to Prevent It

Misconduct in Research – Detecting Falsification

Statistics and Data Management of Clinical Trials

Data Management In Clinical Research

Good Clinical Data Management Protocol

Financial Management of Clinical Trials

Financial Management Fundamentals

Developing A Trial Budget

Budget Worksheet

Final Examination

Competency Exam (52 Questions)

Are you looking for a comprehensive and reliable training program for clinical research coordinator certification?

CCRPS Clinical Research Coordinator Training provides the most advanced, yet easy-to-follow coverage of GCP guidelines. Our program exceeds expectations with checklists, images, and examples that help students apply concepts learned. Upon completion of our program, students are able to pass certification exams with flying colors and are trusted by employers all over the world. Make the smart choice and choose CCRPS for CRC training.

Medical Research Jobs

What is ich gcp certification 2024.

Research Revolution Global Summit – Agenda Now Live!

October 7-8 | Loews Hotel | Atlanta, GA

What does a modern Clinical Research Coordinator do, and how can technology help?

Clinical Research Coordinators (CRCs) play a crucial role in the success of research sites. With a wide range of responsibilities, the CRC is the “heart” of a clinical trial — the champion of the protocol, the guardian of the patients, and the taskmaster of the research team. 

Although the Clinical Research Coordinator’s purpose hasn’t changed, what they do on a daily basis has. In the past few years, most CRCs have gone from managing trials with paper and binders to managing trials with an array of different software programs . 

Unfortunately, adopting software hasn’t solved all of the struggles CRCs face. In a 2021 study, 67.7% of Clinical Research Coordinators said that stress negatively impacts their work performance, even though clinical trial software is available at roughly 78% of research sites. 

So what causes stress for Clinical Research Coordinators, and how can technology do a better job of removing that stress? 

We interviewed several former Clinical Research Coordinators to find out what a modern CRC does, what challenges they face, and how the right technology can lessen those challenges instead of increasing them. Here’s what we learned.

What a modern Clinical Research Coordinator does

When we spoke to former Clinical Research Coordinators, they described two major components of their days: running patient visits and performing administrative tasks. 

Running Patient Visits

A former Clinical Research Coordinator described her day this way: 

A typical day for me started between 6:00 and 7:00 am. My first hour would be spent preparing for patient visits, checking emails, and filing paperwork. My first patient would arrive between 7:00 and 7:30, and I might see up to six or seven patients a day. 

In addition to actually completing the required activities of the visit, I found myself having to document those activities in the medical record (which I had to make copies of). Then I had to transcribe them onto a paper case report form (CRF), enter them into an electronic CRF, and finally, file both the paper CRFs and the copies of the medical record in the patient’s binder. 

Some visits required me to bounce back and forth between different buildings or even different campuses, holding onto those CRFs for dear life while answering phone calls from patients, PIs, sponsors, and other CRCs.

As the Clinical Research Coordinator above noted, CRCs often end up completing multiple Case Report Forms for each patient, both on paper and electronically—and that’s the real problem with participant visits. 

One Clinical Research Manager we interviewed said that participant visits were the best part of her job, because participants were at the center of all she did. However, she noted that all of the paperwork that went along with participant visits was difficult to complete in a single day. This often led to her working long hours, and, in turn, to burnout .

CRCs don’t want to give up meeting with participants, but they want to minimize the amount of time they must spend on repetitive paperwork afterward. That brings us to the second time-consuming component of a Clinical Research Coordinator’s day: administrative tasks. 

Performing Administrative Tasks

The same Clinical Research Coordinator described her day after patients left this way: 

Once all of the patients were discharged, usually eight or nine hours later, I could return to my office to work on my administrative duties. Typically this meant scheduling and tracking patient or monitor visits or performing data entry. 

Other times it could be IRB submissions, budget and contract review, or maintaining the Investigator Site File and regulatory binders. Or maybe reviewing patient records to locate potential candidates, updating study logs, or ordering supplies. 

One time, I even had to chase the FedEx truck down a busy street at 8 o’clock at night to make sure records were shipped on the same day as the visit was conducted, per the study protocol. Regardless of the specific duties I was performing each day, my hours were long and my days were hectic.

The need to work after-hours and perform so much paperwork leads to Clinical Research Coordinators having a high turnover rate. The clinical research industry typically sees turnover rates of 24-29% , while the average U.S. turnover rate is 15% . 

This high turnover rate doesn’t just affect individual Clinical Research Coordinators —it affects the entire clinical trial industry by making trials slower and more expensive. It takes roughly three months and costs $25,000 to train a new clinical research professional. Every time a CRC leaves their position, trials slow down and become far more expensive. 

Managing Communications

One of the most pressing jobs of clinical research coordinators is to manage communication between their team, investigators, and Clinical Research Associates (CRAs). Failure to communicate clearly can lead to:

• Conflicts between site staff and CRAs
• Unmet expectations
• Non-compliance
• Risks to participant safety
• Trial delays
• Wasted time when work has to be redone

Running patient visits while balancing administrative tasks and constant internal communication leads to heavy workloads. And those heavy workloads lead to low job satisfaction and high burnout . But compliant, efficient, and well-integrated technology might be able to help.

The workload of a modern Clinical Research Coordinator

The number of registered clinical trials taking place each year nearly doubled from 2015 to 2021 . But the rate of hiring clinical research professionals hasn’t kept pace. 

The number of clinical trials grew by 12.2% from 2016-2019, while job postings for clinical research professionals only grew by 9.3% .

Clinical research coordinators cite this increased workload and a lack of opportunities for advancement as two major causes of job dissatisfaction. In 2020, 73.9% of Clinical Research Coordinators said they were thinking of changing jobs. They cited strict contracts, heavy workloads, and a lack of recognition as reasons why they were unhappy with their work.

Technology can’t transform sponsor-site contracts or ensure CRCs receive recognition from their leaders. But the right software can help with heavy workloads and long hours by making CRCs more efficient.

How technology can make CRCs more efficient

A Clinical Research Coordinator’s most valuable asset is time. Streamlining research processes increases productivity, efficiency, and document quality, while also reducing CRC stress and burnout. This lets research sites hold onto their most important resource: experienced CRCs.

We’ve created this chart to show areas where CRCs could save time using technology:

Here’s how these time-saving features work:

Team Management Features

Technology can help CRCs communicate more quickly with their team members and with monitors from sponsors or CROs. 

Internally, research sites should embrace technology like a Clinical Trial Management System (CTMS) and an electronic Investigator Site File (eISF). A CTMS can automate clinical trial operations like scheduling follow-up visits for participants or managing finances. 

An eISF, on the other hand, will help Clinical Research Coordinators manage regulatory documents and data collected during the study. CRCs can assign roles to members of their team to ensure everyone only sees the documents and data they have permission to see. 

Internal Training and Communication

A good eISF has multiple functions. A few of those functions include letting CRCs:

• Track their own training and their team’s training for specific studies
• Create tasks and notifications for their coworkers
• Build placeholders to show their coworkers what documents are missing

All of these functions save CRCs time that would otherwise be spent on multiple emails or phone calls. 

If research sites choose an eISF that allows compliant electronic signatures , CRCs can even request eSignatures from investigators and let those investigators sign from their phones or computers. No more running across a hospital campus to an investigator’s office and then waiting around for them! 

With new task management software, clinical research coordinators can devote more of their time to project management and leadership and less of their time to paperwork. To learn more about using digital technology in clinical research, check out the Florence Digital Research Academy .

Trial Management Features

Trial management software helps CRCs save time during study start-up , as well as throughout the trial. A good eISF should offer trial management features like audit trails, expiration dates, and folder structures to help CRCs organize documents without relying on multiple copies. 

Clinical Research Coordinators shouldn’t have to complete paper Case Report Forms and then re-enter the data into a computer. But if CRCs are going to keep only electronic copies, they need to know when those copies have been updated and by who. They also need to know when a document has expired (if it can expire) and where that document is stored. 

A good eISF can help with all of these challenges. Research sites should search for eISFs with features like audit trails, expiration notifications, and clearly defined folder structures to help them keep their documents accurate and compliant. 

With these features, sites can decrease how much time CRCs have to spend on document management. One of Florence’s clients sped up their document cycle time by 41.8% using an eISF with all of these capabilities.

Remote Access for Sponsors and CROs

Sharing documents and data with sponsors electronically can save Clinical Research Coordinators from chasing a FedEx truck down the street at eight p.m. But if CRCs rely on email or shared drives to share documents, they risk compliance errors . 

CRCs need technology designed specifically for clinical trials. This is where remote access software comes in. 

With remote access software, CRCs give their sponsor or CRO permission to view and leave comments on selected documents and data. The monitor can log into the platform to see research sites’ latest documents and source data without needing to visit the sites. This saves CRCs hours of time they used to spend mailing documents or escorting monitors around in person. It also lets monitors instantly see when site staff have updated or added documents, leading to more compliant studies, better communication, and greater trust between site staff and monitors .

Preparing for the future as a clinical research coordinator

Clinical research coordinators will always have a vital role to play in protecting patients and keeping clinical research teams organized. But if CRCs continue working overtime on repetitive tasks like re-entering data or searching for signatures, they will also continue to burn out and leave their positions at greater-than-average rates. 

By retaining experienced Clinical Research Coordinators, research sites will speed up clinical trials and sponsors will save hundreds of thousands of dollars.

But to make this a reality, sites, sponsors, and CROs need to embrace technology that takes the busywork out of being a Clinical Research Coordinator. CRCs should focus on taking care of participants and using their management skills to keep trials running efficiently, not on scanning, mailing, or filing paper. 

Want to learn more about becoming a Clinical Research Coordinator who focuses on serving patients and on project management instead of on paperwork? Check out our Fundamentals of Digital Research course , available for free to all clinical research professionals.

Get in Touch

Global offices.

USA (HQ) 600 Peachtree St. NE, Suite 920 Atlanta, GA 30308

Serbia Bulevar Kralja Aleksandra 84 11000 Belgrade, Serbia

© 2023. Florence Healthcare.

How Do You Become a Clinical Research Coordinator (CRC)?

For the 2023-2024 academic year, we have 112 schools in our MHAOnline.com database and those that advertise with us are labeled “sponsor”. When you click on a sponsoring school or program, or fill out a form to request information from a sponsoring school, we may earn a commission. View our advertising disclosure for more details.

A clinical research coordinator (CRC), sometimes called a clinical trial manager, plays an integral role in medical studies. They typically work under the direction of the principal investigator (PI), who is in charge of designing, conducting, and managing the clinical trial from a high level. The CRC’s job is to support, facilitate, and organize daily clinical trial activities.

Clinical research coordinators also work with the department, sponsor, and institution to guide them through compliance, finances, and personnel issues. In short, the CRC manages the day-to-day clinical operations activities, overseeing and executing delegated tasks to appropriate parties.

Key responsibilities of the CRC include planning and managing the study, enrollment, maintenance, training initiatives, and maintaining compliance with federal, state, and institutional regulations. In addition, they carry out experiments, clinical research, and medical studies. They also engage directly with the trial participants as they screen them for eligibility, develop and implement recruitment strategies, and liaise with all teams throughout the trial. From evaluating research protocols to seeking approval from regulatory committees, CRCs have a broad reach within laboratories, medical centers, and research hospitals.

To secure a job as a CRC, professionals must have at least a four-year bachelor’s degree in a field such as medical technology, microbiology, or public health administration. However, some employers require an additional two-year master’s degree, particularly for management positions.

Typical courses to prepare for this career include biochemistry, biostatistics, healthcare management, mathematics, epidemiology, and human anatomy. Essential job skills include management and communications experience, multi-tasking, and interpersonal skills. In addition, students may have to take and pass a licensing exam to become clinical research coordinators. (See more on certification below).

Additionally, students may consider internships or entry-level jobs working as lab technicians or healthcare workers to get familiar with the typical working environment.

As the medical industry grows, college graduates, especially those with a master’s in clinical research, will be on the front lines of research and development. As a result, students have various career prospects in front of them with an education in clinical research, from medical scientists to natural sciences managers.

Continue reading for a comprehensive guide on achieving the various levels of a clinical research career, followed by helpful resources that can guide students and professionals as they navigate the process.

THANK YOU FOR YOUR INTEREST IN Southern New Hampshire University Online MS - Construction Management

A step-by-step guide to becoming a clinical research coordinator.

Becoming a clinical research coordinator involves many steps, and varied career pathways are available. Below are some of the primary steps to becoming a CRC at different educational stages.

Step 1: Graduate from high school (four years).

Preparation for a career in clinical research coordination should begin with high school chemistry, biology, physics, math, and communications courses that develop foundational knowledge for college-level coursework.

Step 2: Obtain a bachelor’s degree (four years).

When pursuing colleges and universities, students should focus on those offering bachelor of science degrees in health sciences in clinical research administration. Students should dedicate at least four years of full-time work to this degree. These programs generally provide clinical research professionals with the tools to develop medicines and conduct trials and studies. In addition, on-campus and online programs focus on critical administrative and scientific methods regarding clinical research and guidelines to protect human subjects.

George Washington University

For example, George Washington University in Washington, DC, offers a robust online program geared toward working health sciences and clinical research professionals looking to advance in their careers. With an online BSHS (bachelor of science in health sciences) in clinical research administration from George Washington University (GW), students will develop the expertise and skills needed to contribute to the rapidly growing field of clinical research.

The program comprises 120 credits. In addition to the 51 credits, students will need to take nine to 24 credits depending on how many hours they transferred in. Students may transfer 45 to 60 college credits from another institution which are applied toward the general education and advanced standing requirements. Students must earn at least 60 credits at GW to meet the academic residency requirement and fulfill the required courses for the major.

The curriculum includes courses such as basics of clinical research; processes of clinical research; good clinical practices; introduction to monitoring clinical trials; strategic communication for health professionals; pathophysiology; introduction to statistics for health science; introduction to medical informatics; and introduction to regulatory affairs.

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: 24 months

Kent State University

The College of Public Health at Kent State University in Kent, Ohio, offers a bachelor of science in public health (BSPH) program with a concentration in clinical trials research. Offered on-campus and online, this program prepares students for work as clinical trial researchers and managers.

The program emphasizes epidemiology and health research. Required classes in this 120-credit program include clinical epidemiology basics; clinical trial management; scientific writing for clinical research; and an internship in clinical research. Graduates from this program work for contract research organizations, pharmaceutical companies, hospitals, medical schools, universities, and insurance companies.

• Location: Kent, OH
• Accreditation: Council on Education for Public Health (CEPH); Higher Learning Commission (HLC)
• Expected Time to Completion: Eight semesters

A bachelor’s degree can lead to an entry-level position in a clinical organization or institution. It can also help existing clinicians advance within their current jobs. Students wishing to open up even more opportunities for responsibility and salary are encouraged to pursue professional experience and additional education.

Step 3: Gain work experience as a clinical research professional (at least one year).

At this stage, earning at least one year of full-time experience working in a clinical research capacity is advisable. This is a typical requirement to qualify for national certification.

Step 4a: Obtain a graduate certificate (optional, one year).

Students can earn an online graduate certificate in clinical research administration.

George Washington University offers three online graduate certificates in clinical and translational research, clinical research administration, and clinical research practice.

The 21-credit graduate certificate in clinical and translational research quickly prepares graduates for roles such as clinical trial investigators on multi-site projects. Courses include critical analysis of clinical research; clinical investigation; foundations in clinical and translational research; grantsmanship in translational health science; and leadership, professionalism, and team science in clinical and translational research.

The 12-credit graduate certificate in clinical research administration prepares graduates to become strategic leaders who drive success for organizations in the clinical research industry. Courses include Introduction to global regulatory affairs and clinical research; regulatory strategy in the development of therapeutics; the clinical research industry; and quality and risk management.

The 15-credit graduate certificate in clinical research practice prepares graduates for evidence-based practice as principals or co-investigators in clinical research. Courses include research methods for clinical and translational research, clinical investigation, biostatistics for clinical and translational research, and epidemiology translational research.

Students can typically transfer credits earned in certificate programs into a master’s program within the same institution.

• Expected Time to Completion: Clinical and translational research (20 months); clinical research administration (14 months); and clinical research practice (12 months)

Arizona State University

Arizona State University’s Edson College of Nursing and Health Innovation also offers a 15-credit online graduate certificate in clinical research management for those who are looking to increase their knowledge of clinical research and gain a strong foundation as they advance their careers. Students in this program will learn about clinical research regulations, ethics, operations, and data management.

To be eligible, applicants must have completed six months of clinical research experience.

The curriculum includes courses such as responsible conduct of clinical research; clinical research data management and technology implementation; fundamentals of regulatory affairs; and clinical research operations.

• Location: Phoenix, AZ
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: Less than a year

Step 4b: Get a master of science in clinical research management (optional, two years).

Obtaining a master’s degree can increase one’s salary prospects and responsibilities within the field.

For example, ASU’s master’s in clinical research management is an online 33-semester program. A six-semester-hour clinical research project is also required.

Typical courses include clinical research monitoring; fundamentals of regulatory affairs; clinical research operations; clinical research data management and technology implementation; responsible conduct of clinical research; scientific and research review boards; clinical research design and methods; quality assurance and clinical research; and medical device development and regulation.

By the program’s conclusion, students are prepared to seek careers as clinical research coordinators, data managers, social science research assistants, and clinical lab techs.

• Expected Time to Completion: Two years

Step 5: Get certified (timeline varies).

Professionals in this field are strongly recommended to be certified in clinical research. For example, the Society of Clinical Research Associates (SOCRA) offers an internationally accepted certification for professionals to be recognized as Certified Clinical Research Professionals (CCRP®s).

Students must pass an exam to get their certification. The exam schedule is varied and offers time slots at locations all over the United States. There are three distinct pathways to be eligible for this exam. First, applicants must fall into one of the following categories:

• Category 1– Has two years of full-time experience as a clinical research professional (or 3,500 hours part-time during the previous five years)
• Category 2 – Holds a degree in clinical research (associate, bachelor’s, or master’s) and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)
• Category 3 – Holds an undergraduate or graduate certificate in clinical research (at least 12 semester hours or 144 credits); an associate or bachelor’s degree in a scientific (or related) field; and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)

Alternatively, students can seek certification from the Association of Clinical Research Professionals , called the ACRP-CP®. There are three levels of certification: clinical research associate (CCRA), clinical research coordinator (CCRC), and principal investigator (CPI). In addition, ACRP offers prep courses to help students prepare for each test.

To be eligible for the CCRA or CCRC certification exam, candidates have two available pathways:

• Pathway 1 – Clinical research professionals with 3,000 hours of verifiable work experience can sit for the CCRC or the CCRA Exam.
• Pathway 2 – Clinical research professionals with 1,500 hours of verifiable work experience and a clinical research degree can sit for the CCRC or the CCRA Exam.

Please note that there may be substitutions for hours of qualifying work experience and that “designated duties” may differ by the desired certification. Students can learn more about the ACRP’s exam, schedule, application, and eligibility requirements on the organization’s website.

Additionally, the Certified Clinical Research Professionals Society offers several clinical research certification training courses. The content is delivered on-demand to accommodate people’s busy schedules without compromising the highest-quality professional standards.

Here are the several levels of certification and their eligibility requirements:

• Advanced ICH-GCP Certification (AGCPC): The only diplomas needed to enroll in this program are high school or equivalent level education (such as GED).
• Advanced Clinical Trial Assistant Certification (ACTAC): This certification is open to everyone, even to those without a high school diploma or equivalent. High school students intending to work after graduation or interested in healthcare research may benefit from completing this clinical research assistant certification.
• Advanced Clinical Research Coordinator Certification (ACRCC): Candidates must possess a minimum of an associate’s degree.
• Advanced Clinical Research Associate Certification (ACRAC): In order to enroll for this certification, candidates must have a bachelor’s degree in life science or a health-care science, or a graduate degree in medicine.
• Advanced Pharmacovigilance and Argus Safety Certification (APVASC): Candidates for this possess a minimum of bachelor’s degree in life science OR a health-care science
• Advanced Physician Medical Monitor Certification (APMMC): To qualify, trainees must have a degree in medicine, a non-US degree in medicine, or a master’s degree in pharmacy. Physicians with one or more years of exposure to medical research may also qualify.
• Advanced Principal Investigator Physician Certification (APIPC): To be a certified PI, candidates must be practicing physicians. They may also either be the PI or Co-PI of an ongoing clinical research study or have been the ex-PI or former Co-PI of a completed study.

Helpful Resources for Aspiring Clinical Research Coordinators

The following list of professional organizations can assist students and professionals in seeking a career in clinical research.

• National Institutes of Health – The National Institutes of Health offers a free course, “Introductions and Principles and Practice of Clinical Research (IPPCR).” This clinical research coordinator training course focuses on the ethical issues involved in human subject research. It provides an overview of scientific methodologies, principles, and practices required for patient-oriented research. The course is designed for medical and public health professionals or anyone aspiring to join a clinical research career. Topics include ethical issues, biostatistical methods, study design, protocol preparation, patient monitoring, and quality assurance.
• Harvard University’s Clinical and Translational Science Center – The HCCRC offers information for research coordinators. These resources address professional development, training and certifications, helpful tools, and core competencies for the clinical research professional.
• International Association of Clinical Research Nurses – The IACRN is a professional nursing organization that defines, validates, and advances clinical research nursing while supporting the professional development of registered nurses who work with clinical research participants.
• Association of Clinical Research Professionals —The ACRP sets the standards for competence in clinical research. Based in Washington, DC, it boasts over 16,500 members and supports professionals with the membership, training, and certification programs they need to maintain career excellence.
• Oregon Health & Science University – OHSU’s Oregon Clinical and Translational Research Institute’s mission is “To enhance the efficiency and quality of rigorously translating research ideas into impact.” This organization provides various helpful resources and webinars to guide students as they gather the information necessary to pursue a career in clinical research coordination.

Matt Zbrog is a writer and researcher from Southern California. Since 2018, he’s written extensively about emerging issues in healthcare administration and public health, with a particular focus on progressive policies that empower communities and reduce health disparities. His work centers around detailed interviews with researchers, professors, and practitioners, as well as with subject matter experts from professional associations such as the American Health Care Association / National Center for Assisted Living (AHCA/NCAL) and the American College of Health Care Executives (ACHCA).

Related Programs

• 1 Online Master’s in Clinical Research Administration Programs
• 2 Online Doctor of Health Sciences (DHS)
• 3 Online Master’s Degrees in Food Safety – Regulatory Affairs & Quality Assurance
• 4 Online Master’s in Bioinformatics Programs
• 5 Online Master’s in Biotechnology Programs
• 6 Online Master’s in Health Science Programs
• 7 Online Master’s in Regulatory Science Programs – Medical Device, Food & Pharmaceutical Regulatory Affairs

Related FAQs

• 1 Clinical Significance vs. Statistical Significance
• 2 How Do I Become a Clinical Trials Research Nurse?
• 3 What Can You Do with a Degree in Clinical Research Administration?
• 4 What is Clinical Data Management (CDM)?
• 5 What is a Clinical Application Analyst and What Do They Do?
• 6 What is a Clinical Data Analyst?
• 7 What is a Clinical Lab Manager and What Do They Do?

Related Posts

A day in the life of a clinical research associate.

The clinical research associate acts as a liaison between the study's sponsor (e.g., pharmaceutical company) and the clinics where the study takes place. Because results of a clinical trial must be kept entirely transparent and not influenced by the interests of the sponsor, this is a critical role.

A Day in the Life of a Clinical Data Analyst

Every day, health organizations like hospitals, clinics, and physician offices collect data about their patients. This information is used to make data-driven decisions in order to provide the highest level of care to their patients as well as reduce expenses and errors. From the outcome of a particular treatment to a large-scale clinical trial, health data is a critical part of the modern healthcare process. Clinical data analysts help to make sense of the extensive data that is at their fingertips, creating stories that turn numbers into actionable intelligence to improve healthcare outcomes.

Healthcare Debates: Does Costly US Healthcare Fund R&D and Medical Research?

This article explores research and development in the context of greater healthcare expenditures, including looking into the main drivers of healthcare spending, influences on pricing, and where R&D fits into the whole ecosystem.

Pharmaceutical Quality Director – A Day in the Life

Consumers and corporations need to know that the drugs dispensed by pharmaceutical companies are manufactured safely and efficiently. Pharmaceutical quality directors ensure that quality control protocols are followed within the industry’s manufacturing, testing, and inspection procedures.

Closing the Gap: Women Leading Healthcare

Women drive healthcare. They are the industry's biggest consumers and workers. They serve as caregivers in their homes and make most decisions for their family's health. Why is it, then, that of the 40 Fortune 500 healthcare companies, not a single one is helmed by a woman?

CONSULTING SERVICES

RESOURCING SERVICES

MANAGED SERVICES

LEARNING & DEVELOPMENT 


TARGETED SOLUTIONS

Study Activation

Clinical Trials Office

Our Company

How to Become a Clinical Research Coordinator: Everything You Need to Know

Do you want to know how to become a Clinical Research Coordinator (CRC)? What are CRC responsibilities in clinical research? What qualities do CRCs need to succeed? You’ve come to the right place!

Today, the experts at Vitalief are here to guide you through everything you need to know. Let’s get started!

What is a Clinical Research Coordinator?

A Clinical Research Coordinator, commonly referred to as a CRC, is a person who organizes and manages clinical trials for pharmaceutical companies and academic institutions. These organizations rely on Clinical Research Coordinators to manage many aspects of their studies and make sure they’re done in compliance with all laws, regulations, and the study protocol. 

What is a Clinical Research Coordinator’s Job Description?

The basis of a clinical research coordinator’s job description is doing everything it takes to ensure a clinical trial runs smoothly. Some of the responsibilities this includes are:

Setting up clinical trial sites Training the site staff and patients Performing quality control checks throughout the study process Recruiting participants through community outreach programs Screening out ineligible patients at every step of the enrollment process Managing the informed consent process

Clinical Research Coordinators typically work as part of a team that includes statisticians, regulatory coordinators, primary investigators (PIs), and other members of the clinical research staff. They often have managerial responsibilities too.

Managing the Informed Consent Process

One of the most important tasks CRCs are responsible for is introducing the informed consent process to potential study participants. Without informed consent, clinical research cannot move forward ethically.

The informed consent process ensures that patients know the risks and benefits associated with a trial. It also provides the information necessary for them to make an informed decision.  Plus, it provides an open dialogue between everyone involved.

This process requires the CRC to provide participants with all the necessary information about the study, such as:

• Aims and objectives
• The nature of their involvement
• The duration of the study
• The risks and benefits associated with participation
• Any other relevant details

The CRC must ensure that potential participants fully understand this information before they make the decision to participate in the study. 

Other Responsibilities

There are several other CRC responsibilities in clinical research. These include:

• Developing study protocols
• Organizing meetings with investigators and other key stakeholders
• Ensuring compliance with applicable laws and regulations
• Maintaining accurate records throughout the course of the study
• Monitoring safety procedures
• Reporting any adverse events

The CRC, along with the Clinical Research Study Manager and the Regulatory Manager, may also be responsible for compiling and analyzing data from clinical trials and preparing reports to be submitted to ethics committees and regulatory bodies. 

What Skill Sets are Required to be a Good Clinical Research Coordinator?

As a Clinical Research Coordinator, you are required to understand the complexities of clinical trials, as well as the drug development process. The best candidates for this job understand laboratory procedures, have administrative and computer skills, and have excellent communication skills. Clinical Research Coordinators must be detail-oriented and able to work under pressure with strict timelines.

As a Clinical Research Coordinator, the following skills will help you succeed in your role: 

• Emotional intelligence, empathy, and compassion for others who are participating in a clinical trial
• Detail-oriented and know how to read and follow a protocol
• Exceptional communication and interpersonal skills since you will interact with the research team, the primary investigator, clinical staff, and the study participants in written and verbal communications
• Ability to multitask and excellent organizational skills
• Curious, willing to learn, and an analytical mindset

A Clinical Research Coordinator’s job description usually includes administrative tasks such as preparing budgets, filing paperwork, and handling correspondence.

What Education and Training are Required for a Clinical Research Coordinator Role?

In most cases, Clinical Research Coordinators must have at least a bachelor’s degree in life sciences or public health, as well as one year of laboratory experience.

They must also have up-to-date knowledge of relevant scientific literature and an understanding of statistics and experimental design principles.

Clinical Research Coordinators often serve as mentors to other employees in their organization regarding regulatory compliance standards and ethical issues that may arise during clinical trials.

Certifications Required for Clinical Research Coordinators

Professional certification requirements vary by employer, state, and the type of work a Coordinator does. There are numerous certifications that are designed to build a CRC’s skills and knowledge.

Micro-credentialing, such as a badging program, helps to expand knowledge and provide unique training experiences that are specifically designed for certain professional roles. Rutgers has a great program that is specifically geared toward Clinical Research Coordinators. 

The Rutgers CRC Badging Program

The Rutgers Clinical Research Coordinator (CRC) Badging Program is an innovative program designed to provide certification and recognition for individuals who are looking to further their careers in the clinical research field. As part of the program, individuals must complete certain courses and demonstrate a deep understanding of clinical research protocols, practices, and standards.

To meet the requirements of the badging program, candidates will gain knowledge of the Clinical Research Coordinator job description. This includes understanding the essential functions of a research coordinator, such as:

• Developing, managing, and monitoring research protocols and studies
• Collecting and analyzing data
• Preparing reports and presenting results
• Maintaining accurate records and databases
• Troubleshooting any issues that may arise during the course of the study. 

The Rutgers Clinical Research Coordinator Badging Program is a great way to demonstrate your expertise in the field of clinical research coordination and become more competitive in the job market. By obtaining your CRC badge, you can show employers that you have the knowledge and skill necessary to effectively lead clinical research projects.

Professional Career Paths for Clinical Research Coordinators

As a Clinical Research Coordinator, there are many opportunities for professional development. You interact with people in several different roles, from nurses to administrators. This exposure to diverse roles will enable you to explore a myriad of professional opportunities and help you determine the next step in your professional journey. 

If you think you might be interested in pursuing this career path, now is a perfect time! Vitalief is always looking for strong candidates for this role. Check out our CAREERS page to see the different roles we are seeking to fill!

COMMUNICATIONS

Privacy Policy

© 2021-2023 Vitalief. All rights reserved.

Vitalief • New Brunswick, NJ 08901 • United States

By using the website you accept our   privacy policy . Choose your cookie consent:

Advarra Clinical Research Network

Onsemble Community

Diversity, Equity, & Inclusion

Participants & Advocacy

Advarra Partner Network

Community Advocacy

Institutional Review Board (IRB)

Institutional Biosafety Committee (IBC)

Data Monitoring Committee (DMC)

Endpoint Adjudication (EAC)

GxP Services

Research Compliance & Site Operations

Professional Services

Coverage Analysis​

Budget Negotiation​

Calendar Build 

Technology Staffing

Clinical Research Site Training

Research-Ready Training

Custom eLearning

Services for

Sponsors & CROs

Sites & Institutions

BioPharma & Medical Tech

Oncology Research

Decentralized Clinical Trials

Early Phase Research

Research Staffing

Cell and Gene Therapy

Ready to Increase Your Research Productivity?

Solutions for need.

Clinical Trial Management

Clinical Data Management

Research Administration

Study Startup

Site Support and Engagement

Secure Document Exchange

Research Site Cloud

Solutions for Sites

Enterprise Institution CTMS

Health System/Network/Site CTMS

Electronic Consenting System

eSource and Electronic Data Capture

eRegulatory Management System

Research ROI Reporting

Automated Participant Payments

Life Sciences Cloud

Solutions for Sponsors/CROs

Clinical Research Experience Technology

Center for IRB Intelligence

Not Sure Where To Start?

Resource library.

White Papers

Case Studies

Ask the Experts

Frequently Asked Questions

COVID-19 Support

About Advarra

Consulting Opportunities

Leadership Team

Our Experts

Accreditation & Compliance

Join Advarra

Learn more about our company team, careers, and values. Join Advarra’s Talented team to take on engaging work in a dynamic environment.

Roles and Responsibilities of a Clinical Research Coordinator

• Meghan Hosely Marketing Content Manager;

In clinical research, it’s no secret that clinical research coordinators (CRCs) are tasked with an objectively high number of day-to-day tasks when managing any of their studies at any given time. Coordinators spend the majority of their time understanding informed consent forms (ICFs), communicating with the regulatory coordinators, managing subjects already on a protocol, and working heavily with monitors during their on-site visits. However, one of the biggest and most time-consuming tasks for CRCs surrounds study activation and learning protocols for each study they are on. This article will outline the challenges CRCs face, how they can better allocate their time to higher accruing studies, and understanding how to make their institution’s technologies work for them as they manage multiple studies.

Challenges of a CRC

It’s not uncommon for research teams to have a hand in a few different studies at any given time, and in the midst of juggling day-to-day tasks, the main challenge for coordinators is managing all of the protocol intricacies for each study. At any moment, the principal investigator (PI) could identify a potential participant on a different study than the one a CRC is currently focusing on. Study coordinators need to be ready at all times in case a situation like this were to happen.

Keeping a hand in every study and reviewing protocols every once in a while saves CRCs from scrambling to understand a protocol and poorly explaining it to a potential participant. Another major benefit of understanding a protocol is decreasing the chance of a protocol deviation. For example, knowing the timeline between screening a subject and putting them on protocol could be the difference between starting them on time and having to re-screen them. Taking a little extra time to review the timeline benefits study team members and the participants, and avoids any deviations, keeping them on protocol.

Allocating Time Wisely

With so many daily responsibilities, it’s especially important for CRCs to make sure they are making the best possible use of their time. By dedicating specific parts of a day to specific tasks, it allows coordinators to stay more focused on the task at hand without worrying about what’s coming up. If a CRC is on multiple studies at one time, it is also helpful to block out time each week to review studies coming down the pipeline. Reviewing eligibility criteria and ICF requirements early on will save CRCs time in the end. This will be especially helpful as these studies start to come to fruition, and a CRC needs to meet with a potential participant. Being aware of the study at hand will prevent any last-minute, rushed review of a protocol.

If a CRC is working on multiple studies, chances are at least one study is accruing less participants than the others. Oftentimes, a study that had the potential to accrue many participants falls short, and CRCs spend the bulk of their time, in hindsight, overpreparing for the protocol. For studies such as these, it’s important to be aware of the protocol without allocating time to it that would be better used on other, higher-accruing studies.

Utilizing Research Technologies to Its Fullest Potential

While utilizing research technologies may seem like an added step in some cases, it will almost always reap benefits for the study team. If a study team is involved in investigator-initiated trials (IITs) , taking advantage of a CTMS can be very useful. Since the PI acts as the investigating sponsor in the study, everything happening on protocol that normally needs to be communicated with the sponsor is staying internal, the CTMS gives study staff access to all the data points. By using a CTMS for an IIT, the data is already in the system, which not only keeps study staff informed but keeps all of the necessary data in the same place.

In addition to an institution’s CTMS, leveraging other software pieces goes a long way, aiding in a CRC’s daily task list. For example, an eRegulatory binder helps keep documents and signatures housed in one place, easily allowing coordinators to access forms. In these electronic binders, there could be a repository of institutional review board (IRB) approvals for various protocols, up to date ICFs, and other necessary documents for continuing in the protocol.

Operational analytics also has been proven useful to study coordinators in their daily tasks. Users can track task lists and activation trends within a protocol. By doing so, they can see all the steps in the activation lists and understand how far along in each study they are. The operational analytics dashboard will allow coordinators and PIs to see averages on tasks such as IRB approval or contract negotiations. Seeing average timeframes on tasks such as these helps the CRCs and PIs better plan for accrual openings and overall study activation.

Meghan Hosely creates educational content for Advarra, such as blogs, eBooks, white papers, and more.

Back to Resources

Ready to Advance Your Clinical Research Capabilities?

Subscribe to our monthly email.

Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.

Advancing Clinical Research: Safer, Smarter, Faster ™

Copyright © 2024 Advarra. All Rights Reserved.

• Privacy Policy
• Terms of Use
• Cookie Policy

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Mayo Clin Proc Innov Qual Outcomes
• v.5(2); 2021 Apr

Empowering the Clinical Research Coordinator in Academic Medical Centers

Danielle a. buchanan.

a Department of Neurology, Vanderbilt University Medical Center, Nashville, TN

Jody Goldstein

b Huntington Study Group, Rochester, NY

Anna C. Pfalzer

Ya-chen lin.

c Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN

Hakmook Kang

Daniel o. claassen.

To identify factors associated with job satisfaction and retention, we surveyed a large cohort of clinical research coordinators (CRCs). In recent years, the clinical research coordinator has changed from a semi-permanent role to one that has a high turnover rate. The CRCs are integral to clinical research and instability in this role can cause patient stress and increase the burden on clinical teams through unnecessary delegation of resources toward hiring and retraining new talent. The cultural shift toward CRCs as a temporary position may be driven by the perspective that the role positions an individual for other health care careers, but understanding what influences low retention rates are necessary.

A survey containing 13 multiple choice or open-ended and 32 Likert scale questions was distributed to previous and current CRCs using REDCap. The questionnaires were self-administered and completed over a 12-month period between October 11, 2017, and September 16, 2018.

A total of 85 CRCs completed the study. From the 32 potential predictors of retention, we investigated 9 significant predictors: salary, work setting, understanding the role, level of CRC, understanding protocol development, actively engaged principal investigator (PI), having a collaborative role with PI, feeling respected by PI, and having a close relationship with PI. Adequate salary, greater respect, collaboration, and engagement from the PI were significantly associated with higher retention. Surprisingly, greater workload and lack of opportunity for professional growth were not associated with retention.

The CRCs who feel respected and engaged by the PI and are adequately compensated are more likely to have higher job satisfaction and retention.

Clinical research studies are conducted by a multidisciplinary research team including but not limited to clinical staff, regulatory staff, and administrative personnel. The coordination among such a comprehensive team is often led by a clinical research coordinator (CRC), whose daily responsibilities vary significantly but ultimately serve as the liaison between study sponsor and patients and clinical, regulatory, and administrative staff. The CRCs are integral for the success of clinical research due to their wide range in responsibilities. Clinical research coordinators are typically composed of clinical research nurses, clinical trial nurses, research nurse coordinators, and study coordinators. 1 The main tasks that CRCs conduct for multicenter trials include recruitment of patients into clinical trials (screening, enrollment, consent, and randomization), conducting study visits (collecting biofluids, monitoring compliance, and documenting adverse events), maintaining study regulatory documents, reporting adverse events to the appropriate regulatory authorities (eg, institutional review board, sponsor, US Food and Drug Administration, and National Institutes of Health, conducting research in accordance with Good Clinical Practice guidelines, managing study budgets, maintenance of electronic study records, and general liaison between study sponsor and site principal investigator (PI).

Hiring a CRC represents a significant investment in time and training to properly carry out job responsibilities. Turnover in this role is costly; these costs are related to salary, effort of the employee and trainee, time for education and development, marketing and recruitment, loss of productivity during orientation and training, and emotional costs of turnover on current staff. 2 Because of this investment, it is advantageous to retain individuals in this position for extended periods, positioning this role as a long-term career. Currently the CRC role has become a temporary position in which coordinators seek to gain clinical experience before medical school, nursing positions, or other graduate programs.

With the increase in regulatory oversight among clinical trials, the demands and expectations of CRCs have increased and require additional skills, training, and medical knowledge. Depending on experience and interest, CRCs may actively participate in additional investigator-initiated projects, manuscript preparation, and conference presentations. The expansion of the CRC role includes additional responsibilities and increased workload for individuals, which adversely affect their job satisfaction and ultimately duration in the position. A study by Anderson and Milkovich found that job satisfaction was a significant predictor of retention with professional, managerial, and technical employees. 3 Similarly, Gullatte and Jirasakhiran 2 found that lack of job satisfaction was the most cited reason for staff turnover.

Given the important role of CRCs on the success of clinical research and the necessary investment of resources for their success, it is advantageous to identify factors associated with job satisfaction and increased retention. There is limited literature evaluating these factors and the existing studies are less relevant considering the rapid pace at which the structure of clinical research evolves. This study sought to identify specific predictors of retention from 32 different potential factors.

A 45-question online survey was developed by the clinical research team at Vanderbilt University Medical Center and administered over a 12-month period between October 11, 2017, and September 16, 2018. Questions were based on anecdotal reports from CRCs, clinicians and clinical research staff within the clinic, clinicians and research staff at the University of Rochester, and research administrators within the Huntington Study Group. The 45-question self-administered questionnaire used a combination of multiple choice and open-ended (questions 1-13) and 5-point Likert scale (questions 14-45) questions ranging from strongly disagree (0) to strongly agree (5), outlined in Tables 1 and ​ and2. 2 . The questions addressed research setting, duration in position, prior experiences, relationships with study participants and research staff, compensation, professional support, additional training opportunities, and opportunity for career advancement. Information for participant retention was recorded using an ordinal response category with the following duration categories: 0 to 1, 1 to 5, 6 to 10, 11 to 16, and more than 16 years.

Table 1

Multiple-Choice and Open-Ended Survey Questions

CRC = clinical research coordinator.

Table 2

Five-Point Likert Scale Survey Questions

PI = principal investigator.

The study was administered electronically through the secure web platform REDCap, and participants were identified using the Huntington Study Group list serv and professional contacts. The survey was distributed to 113 participants identified as previous or current CRCs from 32 academic medical centers. We collected participant email address, sex, and work setting but did not collect information related to age, previous work background, level of education, or job title (ie, CRN, clinical research associate, or clinical research nurse).

Statistical Analyses

Predictors of retention were identified using logistic regression models with select variables as potential modifiers. Variables were selected based on a principal component analysis bi-plot that identifies groups of predictors with similar responses (Statistical Software R, version 3.5.2). Figure 1 is a visual representation of this bi-plot that identifies the select questions (predictors) that cluster together. This analysis identified 3 clusters of questions containing 9 Likert-scale predictors to be investigated for their role in retention. Single predictor logistic regressions were run on these groups of questions that primarily related to compensation and relationship with the PI. Retention was examined as an ordinal and binary variable (low = 0-5 years and high = 6+ years), yielding no differences in significant predictors between the 2 statistical models and thus only binary comparisons are reported here with the corresponding odds ratio and P value. In an attempt to identify the single most important predictor of retention, we generated a regression model that included all 9 significant predictors of retention. We did not adjust for multiple comparisons. Last, we also examined 8 additional predictors with no clear retention trends but were selected based on anecdotal information. A description of the regression analyses for these variables are outlined in Table 3 . All predictors were examined using an ordinal regression with the exception of “work setting,” which was analyzed using a nominal logistic regression as seen in Figure 3(GraphPad Prism, version 8.3, and the Statistical Software R version 3.5.2).

Table 3

Detailed Univariate Regression Analyses a

Response trends for Likert scale questions. Responses for the 32 Likert scale questions identify several clusters of questions with similar response trends. Each vertical column represents a different question with the number of every fifth question identified on the x-axis (1, 5, 10, etc). The number of participant responses from strongly disagree to strongly agree for each box is indicated with different shades of blue to yellow: blue indicates fewer responses and yellow indicates a greater number of responses as estimated with the vertical scale bar. Clusters of questions are indicated with black bars with an asterisk (∗) identifying a cluster of questions related to the role of the principal investigator that were all significant predictors of retention.

Ethical Considerations

The Vanderbilt University Medical Center Institutional Review Board deemed this survey as exempt because the study poses minimal risk to participants. This study meets 45 CFR 46.101 (b) category (2) for Exempt Review; therefore, a consent form was not used. All responses were deidentified by a participant ID number generated by REDCap.

A total of 85 participants completed the survey between October 2017 and September 2018 from the original 113 questionnaires, for a response rate of 75%. Twelve participants were previous CRCs, whereas 73 were current CRCs. There were 9 male and 76 female participants and 7% (n=6) worked exclusively in an academia, 68% (n=60) worked in a hospital, and 25% (n=22) worked in a private setting. The cluster analysis in Figure 1 visually displays similarities in participant responses for Likert scale questions and identifies several clusters of questions with similar response patterns, including a group of 4 questions relating to the role of the PI. Questions within these clusters were the primary focus for factors predicting retention.

Institutional Factors That Affect Retention

We examined 5 institutional factors as predictors of retention: job setting ( P =.04), salary ( P =.043), CRC job level ( P <.001), understanding job responsibilities ( P =.009), and understanding protocol development ( P =.01) are all significant predictors of retention ( Figure 2 ). We also examined categorical predictors (CRC level and work setting) based on anecdotal interactions with peers. Participants were 9.5 times more likely to have high retention if they worked in an academic setting compared with a private hospital ( P =.04). Participants with increasing satisfaction with their good salary were 1.544 times more likely to have high retention compared with participants less satisfied with their salary ( P =.043). Last, respondents who had a better understanding of protocol development were 2.181 times more likely to have high retention ( P =.01). For every increase in CRC level, there is a 3.75 increase in the odds of high retention ( P <.001). Interestingly, better understanding of the CRC role before starting the position ( Figure 2 D) was associated with reduced likelihood of high retention (odds ratio, 0.6087; P =.009).

Five significant predictors of retention. Agreement with: (A) work setting, (B) clinical research coordinator (CRC) level, (C) good salary, (D) understanding role of CRC, and (E) understood aspects of protocol development. Low retention (Low) defined as 0 to 5 years, and high retention (High) defined as 6 or more years. OR = odds ratio.

Role of PI on Retention

Another major predictor of retention among current and previous CRCs related to the role of the PI. The PI had a significant impact on CRC retention when it relates to being collaborative, engaged, and respectful ( Figure 3 ). The influence of the PI on CRC retention is substantial because there were 4 independent predictors relating to the PI. Participants who believed they had a collaborative role, had a close working relationship, were well-respected, and thought that their PI was actively engaged were 1.770, 3.08, 2.387, and 1.947 times more likely, respectively, to have high retention ( P <.05, P <.001, P <.01, and P <.05).

Four significant predictors of retention related to the role of the principle investigator (PI). Agreement with (A) PI engagement, (B) collaborative role, (C) respect, and (D) a close relationship with the PI was associated with greater odds of higher retention. Low retention (Low) defined as 0 to 5 years, and high retention (High) defined as 6 or more years. OR = odds ratio.

To identify the single most important predictor of retention, we included all 9 significant predictors in a regression model. In this model, the only predictor that retained its significance was having a close working relationship with the PI (data not shown), suggesting that this particular variable best predicts retention.

Factors Unrelated to Retention

The remaining 7 predictors that were not associated with retention were number of trials, professional growth opportunities, healthy work environment, rewarding patient interactions, well-structured work environment, publications and conference presentations, and having enough time to get their work done.

Clinical research coordinators are largely invisible participants in clinical research 4 but their role is critical. According to the Association of Clinical Research Professionals, the success of clinical trials relies on CRCs, who carry out many of the key clinical, administrative, and regulatory compliance duties. 5 A study in 1996 revealed that CRCs performed more than 128 different responsibilities. 6 The CRCs usually interact with patients more than the PI for the duration of a trial. This includes study assessments, scheduling, escorting patients around research facilities, being a caregiver, and even being a patient advocate. 1 Cooper and Lomax 7 state that CRCs make a significant difference in participant recruitment, retention, and study efficiency. The CRCs are not only advocating for the success of the particular study but many times advocate for successful patient treatments. Those roles create a balancing act that the coordinator must face. 4 Research coordinators are there to make sure that patients have a good understanding of the protocol, help patients make an informed decision on whether to participate in a trial, the voluntary nature of a clinical trial, and the ability to withdraw from the study at any point without consequences. 4 Although the PI is responsible for the overall conduct of the clinical trial, the CRC is responsible for the daily activities. 5

Due to the number of roles or duties for which a coordinator is responsible, it is difficult and time-consuming to hire and train new coordinators. Although historically CRCs were considered more long-term career positions, they are more recently viewed as temporary jobs used to provide clinical experience for medical school applications or more competitive clinical research positions. The high turnover also has a detrimental effect on patients because they rely on the coordinator to advocate for them. Although it remains unclear why the CRC is now considered a transient position, 1 potential explanation is the lack of professional identity for these roles, leading to unclear training requirements and job criteria. 4 Thus, we sought to better understand factors associated with CRC retention.

We found several predictors of job retention among current and previous CRCs. These predictors relate to job setting, understanding of the position, and salary, as well as another group of predictors related to the role of the PI. Specifically, we found that individuals working in an academic or private research setting had a nearly 10 times greater odds of higher retention (OR=9.5) compared with individuals in a hospital environment. One potential explanation for this association is the well-known discrepancy in salaries across academia, medical centers, and private research institutions, although salary did not significantly alter the relationship between work setting and retention ( P =.04).

Clinical research coordinator is often an entry-level position and has salaries corresponding to clinical positions with little or no experience. However, it is clear that the odds of having higher retention is 1.54 times more in those who considered their salary competitive ( Figure 2 ). It then becomes imperative that medical centers and academic institutions conduct ongoing market surveys for proper compensation. 2 It is also important for employers to systematically acknowledge and compensate CRCs for increased productivity and job duration. Figure 2 shows that approximately 60% of participants with a low retention group noted a low salary. A study by Gardner et al 8 found that pay level was significantly related to both organizational self-esteem and performance. Furthermore, employees who received higher pay felt more highly valued and in return had higher job performance. 9 Interestingly, no participant endorsed being compensated based on job productivity. These studies suggest that higher salaries or even financial incentives may promote increased productivity and longer retention among employees.

Relatedly, CRC position was another significant predictor of retention among participants. Position level typically corresponds to an individual's previous experience or reflects job duration. It seems likely that the association between CRC level and retention may also be influenced by salary, promotion success, and support of the institution.

Understanding the role and responsibilities of a CRC position (including protocol development) are additional predictors of retention. Interestingly, the more an individual understands the responsibilities of the CRC position, the less likely they are to have high retention ( Figure 2 D). This may be a result of the breadth of responsibilities and the increase in administrative burden on the position compared with the hands-on clinical experience most employees seek in this role. It is possible that the relationship between retention and understanding the role of the CRC is affected by an individual’s education level, although for this study we did not specifically gather information regarding respondents' previous education levels or training experience. Interestingly, the survey included a question related to adequacy of training ( Table 2 , question 3) for their current CRC role, and this was not a significant predictor of retention. Conversely, an individual’s involvement in protocol development results in 2.181 greater odds of higher retention. Participation in protocol development would occur primarily in investigator-initiated trials and a coordinator may feel a greater sense of autonomy and understanding of clinical research.

The second primary cluster of significant retention predictors related to the role of the PI. It is common to see PIs who oversee a large amount of clinical trials, have extensive clinical responsibilities, are committed to expanding investigator-initiated trials, run laboratories, and teach, in addition to travel requirements. Although the National Institutes of Health define the PI as the individual who is primarily responsible for the clinical trial, 10 it is clear to all research staff that CRCs more often complete many of the responsibilities formally designated to the PI. 11 The demands on a successful PI are extensive and as a result, a CRC may feel a lack of engagement or support from their PI and other research staff. Participants who did not feel engaged with their PI were 90% less likely to have high retention ( Figure 3 A). A PI who is actively engaged with a sponsor-initiated CRC would be readily available to sign source documents, identify potential study participants, and review laboratory test results and other time-sensitive documents that sponsors may require. A PI who is actively engaged in the research outside of a clinical trial would help with data interpretation and provide opportunities for authorship 5 and professional growth.

Additionally, we found that the odds of having higher retention is 77% greater in participants who thought that their PI was collaborative ( Figure 3 B). According to a recent study, effective managers are identified as those who take time to manage relationships with their employees as well as their bosses. 12 It is clear that investing in a professional relationship between CRC and PI involves utilizing each other's strengths and making up for each other's weaknesses. 12 Clinical research is a multidisciplinary field that relies heavily on the camaraderie of all participants. As such, the stronger the relationship between team members and the PI, the longer people will want to stay. To this extent, we found that a participant is more than 3.08 times more likely to have high retention when they have a close working relationship with their PI ( Figure 3 D). Furthermore, in a multiple regression model that includes all 9 significant predictors identified in this study, having a close working relationship with the PI is the single most important predictor of retention. A previous study found that employers who demonstrated a sense of motivation, interest, and concern for their employees' well-being led to higher retention. 13

Respect from the PI is the final predictor of retention. One reason for high turnover rates among health care professionals is perhaps due to a lack of recognition and positive feedback from their employers. 9 To this end, we found that the odds of having higher retention is 2.387 times more likely than for someone who believed they were not respected by their PI ( Figure 3 C). According to Sow et al, 13 employees have higher retention in organizations in which the employer provides consistent positive feedback and recognition.

Ultimately, we found that although salary and compensation were a significant predictor of retention among this select population of clinical research staff, greater predictors of retention related to the involvement and relationship with the PI. These findings will have significant implications for PIs, who may have limited resources or limited institutional means with which to increase salaries. We show that the investment in time to build genuine relationships with study staff is just as likely to increase long-term retention as better compensation.

Acknowledgements

This work was supported by Huntington Study Group Executive Coordinator Council.

Potential Competing Interests: The authors declare no competing interests.

Hourly Wage for Clinical Research Coordinator Salary in the United States

Hourly Wage for Clinical Research Coordinator Salary

How much does a Clinical Research Coordinator make hourly in the United States? The average hourly wage for a Clinical Research Coordinator in the United States is $34 as of July 29, 2024, but the range typically falls between $29 and $39 . Hourly rate can vary widely depending on many important factors, including education , certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, Salary.com helps you determine your exact pay target. 

• Paid Annually
• Paid Monthly
• Paid Semimonthly
• Paid Biweekly
• Paid Weekly
• Paid Hourly

Clinical Coordinator (RN) - Emergency Department

VCU Health - South Hill, VA

Clinical Coordinator RN

Trinity Woods - Tulsa, OK

RN, Registered Nurse Clinical Care Coordinator - CM Pre-Screening - Full Time

Christus Health - Texarkana, TX

Dialysis Clinical Coordinator - RN

US Renal Care - Quincy, MA

• View Average Salary for United States
• Select State
• Select City
• Choose Similar Job
• Pick Related Category
• View Cost of Living in Major Cities

What skills does a Clinical Research Coordinator need?

Each competency has five to ten behavioral assertions that can be observed, each with a corresponding performance level (from one to five) that is required for a particular job.

Products and Services: Knowledge of the full array of our organization's products and services including those that are created for internal customers; insight into the differentiating factors that distinguish them from those of competitors.

Clinical Support: Assists healthcare professionals in the delivery of patient care. They work with an individual practitioner or a team, taking on tasks such as welcoming and preparing patients, explaining treatment and updating patient records

Staff Training: Staff training is a programme implemented by a manager or person of authority to provide specific staff members with the necessary skills and knowledge for their current role.

Analyze the market and your qualifications to negotiate your salary with confidence.

Search thousands of open positions to find your next opportunity.

Individualize employee pay based on unique job requirements and personal qualifications.

Get the latest market price for benchmark jobs and jobs in your industry.

What Should I Pay?

Job Description for Clinical Research Coordinator

Clinical Research Coordinator organizes research information for clinical projects. Selects and observes subjects and assists with data analysis and reporting. Being a Clinical Research Coordinator oversees experiment scheduling and collection of data. Requires a high school diploma or equivalent. Additionally, Clinical Research Coordinator typically reports to a supervisor or manager. The Clinical Research Coordinator works under moderate supervision. Gaining or has attained full proficiency in a specific area of discipline. To be a Clinical Research Coordinator typically requires 1-3 years of related experience. (Copyright 2024 Salary.com)... View full job description

Employers: Job Description Management Tool

See user submitted job responsibilities for Clinical Research Coordinator.

Our job description management tool- JobArchitect streamlines your job description process. Say goodbye to the hassle of crafting job descriptions.

Does your employee feel unfair treatment? See our CompAnalyst ® Pay Equity Suite can help you achieve and sustain pay equity with the true end-to-end solution.

Search Job Openings

Salary.com job board provides millions of Clinical Research Coordinator information for you to search for. Click on search button below to see Clinical Research Coordinator job openings or enter a new job title here.

• Clinical Coordinator RN Trinity Woods - Tulsa, OK Job Requirements. Licensed as a registered nurse in the State of Oklahoma. Minimum of two (2) years work experience as a nurse in a long-term care environm... - 14 Days Ago
• RN, Registered Nurse Clinical Care Coordinator - CM Pre-Screening - Full Time Christus Health - Texarkana, TX Description. Summary. The Registered Nurse Clinical Care Coordinator is responsible for evaluating, coordinating, processing, screening, and documentation ... - 15 Days Ago
• Dialysis Clinical Coordinator - RN US Renal Care - Quincy, MA Mission Diversity Inspiration Growth. OUR MISSION. At U.S. Renal Care, we're changing the lives of everyone living with kidney disease. OUR DIVERSITY IS OU... - 5 Months Ago
• Clinical Coordinator Respiratory Therapy Johns Hopkins Medicine - Columbia, MD Job Description. Job Description. Johns Hopkins Howard County Medical Center. Johns Hopkins Howard County Medical Center is a private, not-for-profit, comm... - 28 Days Ago

Career Path for Clinical Research Coordinator

A career path is a sequence of jobs that leads to your short- and long-term career goals. Some follow a linear career path within one field, while others change fields periodically to achieve career or personal goals.

For Clinical Research Coordinator, the first career path typically progresses to Clinical Research Manager.

Company Description

What does a clinical research coordinator do, are you an hr manager or compensation specialist.

Salary.com's CompAnalyst platform offers:

• Detailed skills and competency reports for specific positions
• Job and employee pricing reports
• Compensation data tools, salary structures, surveys and benchmarks.

Clinical Research Coordinator Pay Difference by Location

Clinical Research Coordinator salary varies from city to city. Compared with national average salary of Clinical Research Coordinator, the highest Clinical Research Coordinator salary is in San Francisco, CA, where the Clinical Research Coordinator salary is 25.0% above. The lowest Clinical Research Coordinator salary is in Miami, FL, where the Clinical Research Coordinator salary is 3.5% lower than national average salary.

Similar Jobs to Clinical Research Coordinator

Level of Education for Clinical Research Coordinator

Jobs with different levels of education may pay very differently. Check the Clinical Research Coordinator salary of your education level.

• Clinical Research Coordinator Salaries with a High School Diploma or Technical Certificate
• Clinical Research Coordinator Salaries with an Associate's Degree
• Clinical Research Coordinator Salaries with a Bachelor's Degree
• Clinical Research Coordinator Salaries with a Master's Degree or MBA
• Clinical Research Coordinator Salaries with a JD, MD, PhD or Equivalent

Clinical Research Coordinator Salary by Global Country

Clinical Research Coordinator salary varies from country to country. There are several factors that mainly impact the Clinical Research Coordinator salary, including cost of living, economic conditions, market rates and legal differences. Click below to Clinical Research Coordinator salary of the other country.

• United States

Clinical Research Coordinator Salary by State

Geographic variations impact Clinical Research Coordinator salary levels, due to various factors, such as cost of living, industries, market demand and company budgets. Click below to see pay differences between states.

Browse All Healthcare - Administrative Jobs by Salary Level

Browse related job categories with clinical research coordinator.

A job category is a classification or grouping of job positions that share similar characteristics, functions, or industries. Clinical Research Coordinator salary varies from category to category. Click below to see Clinical Research Coordinator salary in different categories.

Take just three simple steps below to generate your own personalized salary report

Understand the total hourly compensation opportunity for a Clinical Research Coordinator, hourly wage plus other pay elements

Average hourly wage.

Core compensation

Average Total Hourly Cash Compensation

Includes base and short-term incentives

Discover how your pay is adjusted for skills, experience, and other factors

How much should you be paid.

For a real-time salary target, tell us more about your role in the four categories below.

Your estimated salary based on up-to-date market data and the factors you selected below

View the Cost of Living in Major Cities

Skills associated with Clinical Research Coordinator: Medical Writing , Clinical Research , Participant observation , Scheduling ... More

Recently searched related titles: Tmf Specialist , Clinical Research Data Specialist , Clinical Research Physician

Jobs with a similar salary range to Clinical Research Coordinator : Clinical Trial Specialist , Research Study Coordinator , Senior Research Coordinator , Research Associate , Clinical Study Coordinator

Salary estimation for Clinical Research Coordinator at companies like : Activa Pharmaceutical Inc , Lake Sayoc Training Group , Shoprite Supermarkets , Inc NPI 1619082492

Jobs with a similar salary range to Clinical Research Coordinator : Water Resource Consultant , Research Regulatory Coordinator , Post Doctoral Fellow

COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Clinical Research Coordinator

• Herbert Irving Comprehensive Cancer Center
• Columbia University Medical Center
• Opening on: Aug 20 2024
• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Salary Range: $62,400 - $65,000

Position Summary

The Clinical Research Coordinator manages clinical trials conducted through the Clinical Protocol & Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to. The Clinical Research Coordinator manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests/visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Responsibilities include, but are not limited to:

GENERAL STUDY MANAGEMENT

• Reviewing research protocols
• Assisting Principal Investigators in drafting budgets and submitting studies
• Interacting with the regulatory office to maintain regulatory documentation and administrative files for each protocol
• Under the supervision of the clinical research management office supervisor, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.
• The coordinator will also comply with necessary regulatory responsibilities

PATIENT MANAGEMENT

• Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center, and other study staff
• Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials
• Communicating with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests
• Collecting follow-up data on patient post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols
• Completes timely research billing review
• Maintains and updates sponsor-related, university and department databases/logs

DATA MANAGEMENT

• Handling data management requirements for each patient enrolled
• Abstracts, assembles, and organizes clinical research data
• Coordinator performs other related duties and participates in special projects as assigned

Minimum Qualifications

• Bachelor’s Degree or equivalent in education, training, and experience.

Preferred Qualifications

• Experience in a clinical research setting with knowledge of HIPAA and GCP.

Other Requirements

• Excellent interpersonal and organizational skills.
• Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

Thank you - we'll send an email shortly.

Other Recently Posted Jobs

Coordinator

Administrative coordinator, director, payroll-hybrid schedule.

Refer someone to this job

• ©2022 Columbia University
• Accessibility
• Administrator Log in

Wait! Before you go, are you interested in a career at Columbia University? Sign up here! 

Thank you, for sharing your information. A member of our team will reach out to you soon!

This website uses cookies as well as similar tools and technologies to understand visitors' experiences. By continuing to use this website, you consent to Columbia University's usage of cookies and similar technologies, in accordance with the Columbia University Website Cookie Notice .

A Day In The Life of Clinical Research Coordinators

In this day in the life guide, you will find out:

• What does a day as Clinical Research Coordinators looks like
• What do they do every day
• Things they do on a weekly or monthly basis
• How many hours do they work

The purpose of this is to give you a clear picture of this career so you can make a better career decision on whether this career is suitable for you or not.

Video coming soon

Top 2 Featured Schools For Clinical Research Coordinators

Typical day for clinical research coordinators.

Here is a list of tasks that Clinical Research Coordinators do every day.

• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.

Weekly and Monthly Tasks

Here is a list of tasks that Clinical Research Coordinators do on a weekly or monthly basis.

• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Participate in preparation and management of research budgets and monetary disbursements.
• Communicate with laboratories or investigators regarding laboratory findings.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.

Working Hours

• How many hours do Clinical Research Coordinators work per week? More than 40 hours per week
• What is the work schedule like? Regular (Set schedule and routine)

Work Environment

Indoors, Environmentally Controlled

Learn more about Clinical Research Coordinators

Overview | Job Description | Salary | Requirements | Is This Career Right For Me

Related careers to Clinical Research Coordinators

Risk Management Specialists Regulatory Affairs Managers Financial Analysts Administrative Law Judges, Adjudicators and Hearing Officers

This career is also closely related to Clinical Data Coordinator, Clinical Operations Specialist, Clinical Program Coordinator, Clinical Program Manager, Clinical Project Manager, Clinical Research Administrator, Clinical Research Associate (CRA), Clinical Research Coordinator, Clinical Research Director or Clinical Research Manager.

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed .

• Current Employees
• Duke & Durham
• Human Resources
• Connect With Us
• External Applicants
• Current Duke Employees
• Duke Health Careers

Clinical Research Coordinator

Durham, NC, US, 27710

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Brain Tumor Center. The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 45% Effort

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, and SOPs. May train others in these policies and processes. Prepares for and provides support for study audit visits, including support for the reviewer. Prepares for DCI routine Monitoring Visits (DCI MV) and serve as point of contact for the DCI Monitoring Team (MT) and Safety Oversight Committee’s (SOC’s) expectations. Addresses and corrects findings. 

Maintains participant level documentation for all assigned studies, and/or require access to the Duke EHR.  Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for minimal risk studies.  Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Act as clinical liaison between Surgical, Biorepository and Clinical Research teams to coordinate tissue and biospecimen collection for IRB approved protocols within PRTBTC. Run reports to identify and prescreen eligible patients to be presented with a consent forms for tissue bank studies.  Build and maintain daily schedule to coordinate in-clinic or eConsent by data staff for the potential patients identified.  Track patients who consented across different platforms: Spreadsheets, Enrollment logs, REDCap or other platforms that may be established in future. 

Maintains spreadsheets and Enrollment logs for biospecimen collected for tissue banking studies for current IRB approved protocols and future research.  Employ strategies to maintain recruitment and retention rates and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Evaluate processes to identify issues related to recruitment and retention rates; offer solutions.  Maintain study's compliance with institutional requirements and policies.  Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record.

Record adverse events [AE]and report promptly.  Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Assist with the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs].  Assist with the coordination of external monitoring boards. Follow procedures and documentation of study payment and participant care expenses in a timely fashion.  Monitor financial study milestones and report appropriately.  Coordinate with financial teams and participate in budget development.  Assist with study budgets and closeouts.

Employ strategies to maintain recruitment and retention rates and assist participants with individual needs.  Collect information to determine appropriate study feasibility, recruitment and retention strategies.  Evaluate processes to identify issues related to recruitment and retention rates; offer solutions. 

Coordinate study activities with teammates and colleagues to successfully implement and conduct the study.  Recognize and offer solutions to study problems. Escalate issues appropriately.  Take part in site initiation and closeout visits.  Assist in the development of new studies.

Communication – 20% Effort

Serve as primary liaison with sponsors, study personnel and PI for assigned studies.  Collaborate, and communicate with other study personnel as required.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Refer more complex questions and escalate issues to others as appropriate.  

Data – 10% Effort

Use Electronic Data Capture [EDC] systems and enter data accurately.  Detect issues related to data capture, collection or management and suggest solutions. Collaborate to develop REDCap database for data capture for minimal-risk studies. Reconcile spreadsheets with Oncore, REDCap and Master Biospecimen Trackers for all tissue banking studies.

Coordinate and implement procedures to collect IRB approved data from patient charts, medical records, archival records, interviews, questionnaires, and other sources; code, evaluate and interpret collected data and prepare appropriate documentation. Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitor patients' progress. Enters and collects data. Develops data entry or collection SOPs or tools.

May provide oversight or training to study team members collecting or entering data. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Under supervision, develops validation and testing scripts for EDCs for new studies. Executes testing process after the completion of a build, or following any project changes or system upgrades.

Follows policy related to 21 CFR Part 11 compliance, and under supervision may conduct some testing and documentation for Part 11 projects. Provide data in response to “Data Pull requests” by clinicians/researchers for IRB approved protocols in a timely manner. Develops reports on study progress for the PI and other study team members and collaborators. Prepares data for deposit in repositories following publication or study closeout.

Prepares tables, data visualizations, and lay summaries to communicate study results with participants. Identifies data retention requirements that apply to the study from funders, data providers, and/or the institution. Follows applicable data retention and destruction requirements.

May train or oversee others. Creates clear visualizations to help communicate key information to stakeholders.

Under direct supervision from Biostatistician and PI may perform basic analyses on structured data. Under supervision, performs-identification on allowable data to Safe Harbor standards. Comply with required processes, policies, and systems to ensure data security and provenance.  Recognize and report vulnerabilities related to security of physical and electronic data.  Assist in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.

Use Electronic Data Capture [EDC] systems and enter data accurately.  Detect issues related to data capture, collection or management and suggest solutions. 

Leadership – 10% Effort

Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned.

Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently.

Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Actively network. 

Ethics – 10% Effort

Communicate to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations.  Recognize when staff and patients are having difficulty with the distinction and work hard to help them understand the differences.

Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.

Follow SOPs to conduct and document consent for participants for minimal risk studies. Assists with the development of consent plans and documents for participants.

Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Other work as assigned. The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Minimum Qualifications

Completion of an Associate's degree. Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position.

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience. The preferred candidate will have oncology or research experience, training, education or clinical trials coordination experience.   

Job Code: 00001201 CLINICAL RESEARCH COORDINATOR Job Level: 52

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobsat Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.

Clinical Research Coordinator Associate (Fixed-term 2 years)

🔍 school of medicine, stanford, california, united states.

The Stanford University Anesthesiology Department is seeking a Clinical Research Coordinator Associate (Fixed-term 2 years) to help conduct and coordinate research studies on older surgical patients. These studies include a focus on relationships between postoperative delirium/confusion/dementia, intraoperative brain EEG responses to anesthetics, and both CSF and neuroimaging biomarkers.   The coordinator will work under the supervision of Dr Miles Berger in the multispecialty division (neuroanesthesiology section), and will help enroll patients and will be taught how to process biofluid samples, how to perform EEG recordings, and how to conduct functional MRI scans on study patients. Work under close direction of the principal investigator and/or study coordinator/supervisor. Excellent position for those taking 2 or more gap years before applying to medical school, graduate school or MD/PhD programs.

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.

At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.

For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.   Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.   Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.   Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.   Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.  

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

As described below, plus comfortable working in the Operating Room Environment, and with older surgical patients. Outstanding organizational skills, highly conscientious, and high level of attention to detail.

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

Occasional evening and weekend hours.

WORK STANDARDS

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,  http://adminguide.stanford.edu .

The expected pay range for this position is $31.73 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Fixed-Term
• Requisition ID: 104367
• Work Arrangement : Hybrid Eligible

My Submissions

Track your opportunities.

Similar Listings

 School of Medicine, Stanford, California, United States

📁 Research

Post Date: Jan 29, 2024

Post Date: Aug 05, 2022

Post Date: Aug 16, 2024

Global Impact We believe in having a global impact

Climate and sustainability.

Stanford's deep commitment to sustainability practices has earned us a Platinum rating and inspired a new school aimed at tackling climate change.

Medical Innovations

Stanford's Innovative Medicines Accelerator is currently focused entirely on helping faculty generate and test new medicines that can slow the spread of COVID-19.

From Google and PayPal to Netflix and Snapchat, Stanford has housed some of the most celebrated innovations in Silicon Valley.

Advancing Education

Through rigorous research, model training programs and partnerships with educators worldwide, Stanford is pursuing equitable, accessible and effective learning for all.

Working Here We believe you matter as much as the work

I love that Stanford is supportive of learning, and as an education institution, that pursuit of knowledge extends to staff members through professional development, wellness, financial planning and staff affinity groups.

School of Engineering

I get to apply my real-world experiences in a setting that welcomes diversity in thinking and offers support in applying new methods. In my short time at Stanford, I've been able to streamline processes that provide better and faster information to our students.

Phillip Cheng

Office of the Vice Provost for Student Affairs

Besides its contributions to science, health, and medicine, Stanford is also the home of pioneers across disciplines. Joining Stanford has been a great way to contribute to our society by supporting emerging leaders.

Denisha Clark

School of Medicine

I like working in a place where ideas matter. Working at Stanford means being part of a vibrant, international culture in addition to getting to do meaningful work.

Office of the President and Provost

Getting Started We believe that you can love your job

Join Stanford in shaping a better tomorrow for your community, humanity and the planet we call home.

• 4.2 Review Ratings
• 81% Recommend to a Friend

View All Jobs

Clinical Research Coordinator Technician

How to apply.

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

The University of Michigan Congenital Heart Center is seeking an experienced, positive, highly motivated, and organized Clinical Research Technician with excellent communication and multi-tasking skills to join our well-established research team: M-CHORD (Michigan Congenital Heart Outcomes Research and Discovery). M-CHORD consists of a dedicated team of study coordinators, project managers, database analysts, statisticians, a research program manager, and faculty leaders who all support the research endeavors of faculty, staff, and trainees in the congenital heart center. The congenital heart center is very productive in terms of research, with more than 150 publications per year.

The Clinical Research Technician hired into this position will serve as a clinical research study coordinator for both single and multi-center, investigator-initiated and industry-sponsored studies and clinical trials.

A minimum of 2 full in-person days per week is required, though more in-person days may be required over time. The selected candidate may work from home on days where in-person work is not required, as agreed upon with the selected candidate's manager and the PI of the trials and studies to which the study coordinator is assigned.

Responsibilities*

Experience as part of a team with all 8 competency domains is expected.

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Essential**:

25%  Clinical Coordinator Responsibilities (ex.: Performs moderately complex study procedures with accuracy; Triages simple subject concerns and issues appropriately; Assesses studies for execution and troubleshoots potential implementation issues; Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.)

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment

25%  Data Coordinator Responsibilities (ex.: Completes simple to moderately complex data collection during study visits; Resolves simple data queries)

• May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.
• May obtain the CTN number for eResearch applications.
• Completes simple to moderately complex CRFs.
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials.

25%  Regulatory Coordinator Responsibilities (ex.: Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

15%  Administrative Responsibilities (ex.: Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)

• Demonstrates understanding of the clinical research objectives associated with the program.
• May communicate with study participants such as sending study correspondence via mail or email.
• May schedule subjects for research visits and FU appointments.
• May check study calendar for completion of study procedures.
• May manage study supply inventory.
• May utilize documents and systems to track recruitment and retention of participants.
• May complete and activate postings (advertisements, flyers, etc.) independently.
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)

10%  Training (ex.: Participates in training opportunities on Good Clinical Practices (GCP))

• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understands the disease process per program.
• Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.

*Please refer to Clinical Research Career Ladder for specific description of each competency.

**Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The Clinical Research Technician position will most likely support project implementation needs as part of a team. 

Required Qualifications*

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional  for qualifying experience prior to applying.) 
• An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
• Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
• Excellent interpersonal, oral, and written communication skills.
• Demonstrated knowledge of medical and research terminology.
• Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative, and effective manner.
• Exceptional organizational and computer skills are required with proficiency in Microsoft software applications.
• Demonstrated problem solving and conflict resolution skills.  Ability to multi-task, work well under time constraints and meet deadlines.

Desired Qualifications*

• Familiarity with congenital heart disease.
• Comfortable interacting with a pediatric population of varying acuity.

This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall no be held to exclude other duties not mentioned that are of a similar kind or level of difficulty. 

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes .

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Get the Reddit app

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

As a Clinical Research Coordinator - how many trials are you responsible for and what does your role require of you?

Such as how does your site operate with your role? What are your responsibilities? How many active patients do you have and what diseases do you work with?

By continuing, you agree to our User Agreement and acknowledge that you understand the Privacy Policy .

Enter the 6-digit code from your authenticator app

You’ve set up two-factor authentication for this account.

Enter a 6-digit backup code

Create your username and password.

Reddit is anonymous, so your username is what you’ll go by here. Choose wisely—because once you get a name, you can’t change it.

Reset your password

Enter your email address or username and we’ll send you a link to reset your password

Check your inbox

An email with a link to reset your password was sent to the email address associated with your account

Choose a Reddit account to continue