clinical research associate course in canada

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Hazel McCallion

From: Tuesday, 02 July 2024

To: Monday, 30 September 2024

Updated: about 2 months ago

From: Thursday, 27 June 2024

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Ontario College Graduate Certificate

Clinical research.

Co-op | 1 year (2 semesters)

( Remote Learning )

Admission Requirements

• Fees & Financial Aid

Learning Outcomes

Learn how to lead clinical research studies from start to finish., program overview, become a well-rounded clinical research specialist.

Develop both the general and specialized skillsets needed to work in clinical research. In your first semester, you'll learn fundamentals of clinical trials, research methods, project management, regulations, quality and compliance, good practices and more. You'll then build on that knowledge with training in oncology, immunology, cardiology, neurology, medical devices and diagnostics.

Online learning that simulates in-person experiences

Study in the comfort of your own home while still getting hands-on experience. This program is delivered remotely, preparing you for an industry that conducts most of its work online. Video lectures are supported by virtual reality (VR) labs that simulate a real-world consenting room, enabling you to interact with patients and doctors. All costs of your VR equipment will be covered in your fees.

Join a growing field and get paid during your placement

The use of evidence-based medicine is growing globally, prompting governments to invest more money in research and development. The high demand for clinical research associates enables you to be paid during a 360-hour in-person placement at the end of your program. We'll help you secure your co-op at a clinical research organization, hospital, research institution or office in your area.

Upgrade your existing skillset

Government oversight of clinical trials has increased and any violation of research regulations can be extremely damaging to a company's reputation. Even if you're already working in this field, upgrading your knowledge and skills could make you more attractive to employers. You can also apply to receive credit for previous workplace experience or learning , giving you a head start towards your new credential.

This program is delivered fully online and requires faculty and students to participate in real-time according to a fixed provided schedule. Classes are scheduled for a specific day and time.

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Faculty of Applied Health & Community Studies

Designation

Online,  Remote Learning

Helpful links

Program Summary

Program information session

Learn more about this program and get answers to any questions you have!

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Creative, innovative learning is at the core of all Sheridan’s courses. Here are the courses you’ll take in this program.

Total credits: 19

Total credits: 23

Courses subject to change.

Current students should refer to their ⁠ Academic Requirements in myStudentCentre to track their academic progress and outstanding course requirements.

Program Eligibility

• Postsecondary bachelor’s degree, advanced diploma or diploma majoring in life science, health science or a related field.*
• Other professional degree designations such as a MA, PhD, MD majoring in life science, health science or a related field* will be considered.
• Minimum overall GPA of 65%
• The results of their Letter of Intent

Applicant Selection

Candidates to the program are selected on the basis of academic achievement and the evaluation of a Letter of Intent that demonstrates their interest in the industry.

Sample Letter of Intent submission instructions (for reference purposes only) are available.

Domestic applicants

• Postsecondary transcripts indicating courses completed to date must be submitted to ontariocolleges.ca at the time of application.
• Domestic applicants with education outside of Canada must have their transcripts assessed for equivalency through ICAS or WES. A comprehensive (course-by-course) postsecondary credential assessment is required.
• Private career college courses and/or credentials are not accepted as admission requirements for Sheridan programs.

English Language Proficiency

All applicants whose first language is not English must meet Sheridan’s English proficiency requirements .

*Related fields

Postsecondary programs related to life or health science include, but are not limited to:

• Biology, biochemistry, biomedical
• Biomedical engineering
• Health policy / health studies
• Health sciences
• Health-care administration or management
• Homeopathic medicine
• Human kinetics, kinesiology
• Life sciences
• Medical laboratory science
• Paramedic, paramedicine
• Pharmacology
• Physical therapy, occupational therapy
• Public health
• BSc psychology
• Veterinary sciences

For applicants with education credentials in a related field that may not be in the life or health science, relevant experience is also very important for consideration into the program.

Career Opportunities

As a graduate of this program, you’ll be prepared to contribute to clinical research projects in a variety of roles.

Potential career opportunities include:

• Clinical Research Associate
• Data Entry Coordinator
• Clinical Research Coordinator
• Clinical Research Manager
• Project Manager
• Research Program Manager
• Clinical Research Assistant
• Clinical Trial Monitor

Following successful completion of two online academic semesters, students in this program complete a mandatory 360-hour in-person co-op semester. We'll help you secure your co-op at a clinical research organization, hospital, research institution or office in your area.

The program-specific academic standard required for participation in co-op can be found here: Academic Standards for Co-op and Internship .

Cooperative Education is a form of work-integrated learning that links classroom learning with paid or unpaid work experience within a professional environment. Co-op work terms are related specifically to the academic studies of each student. The work terms provide an opportunity to learn by doing. You’ll apply theory to practice, develop a meaningful view of the working world, and cultivate an awareness of yourself as a professional.

Students receive in-class and 1-on-1 career education support to help prepare for the work term. The co-op component is delivered by Sheridan’s Cooperative Education Office, which facilitates over 1,800 Co-op/Internship work terms per year Sheridan-wide.

Learn more about Cooperative Education and Internships at Sheridan .

Degree Completion

Advanced entry challenge exams, get credit for what you know.

Sheridan recognizes and appreciates that advanced learning doesn’t always require standard classroom instruction, and that opportunities to advance skills and learn new technologies are everywhere.

If you have significant knowledge and experience in programming, web development, database and/or networking, you may choose to complete Advanced Entry Prior Learning Assessment and Recognition (AEPLAR) Challenge Exams for academic credit towards your Sheridan Computer Systems Technology advanced diploma.

How do Challenge Exams work?

AEPLAR Challenge Exams are administered by and through the Sheridan College Assessment Centre or through an approved Test Centre. There are fees to write each exam (an Assessment Centre fee and a Challenge Exam fee).

Your completed Challenge Exam(s) will be evaluated to determine whether you’re eligible for credit in one or more courses within the identified program streams.

Prior Learning Assessment and Recognition (PLAR) and Advanced Standing credits are subject to Sheridan’s policies and procedures. Learn more about Sheridan’s Credit Transfer policies and procedures .

I have previous postsecondary education. Should I write a Challenge Exam?

No. Challenge Exams are designed for applicants with knowledge and experience gained outside of formal education. If you have previous postsecondary education, we encourage you to apply for Advanced Standing instead — you may be eligible to apply your previously earned credits towards your new program at Sheridan .

What subjects can I complete Challenge Exams for?

Challenge Exams for applicants to the Computer Systems Technology – Software Development and Network Engineering program are designed to test skills in specific knowledge streams within this program:

• Programming – Introductory
• Programming – .NET
• Programming – Advanced Java
• Web Development
• Operating Systems
• Software Design
• Mobile App Development – Android
• Mobile App Development – iOS
• Game Development – UNITY

You can also choose to complete Challenge Exams for specific individual courses within the Computer Systems Technology program.

Complete a free self-assessment test to help you determine whether Challenge Exams are a good option for you.

How do I apply to complete a Challenge Exam?

Step 1: make sure you meet the program admission requirements.

You must meet the program admission requirements to be eligible for admission and PLAR.

Step 2: Complete a free self-assessment

Complete a free self-assessment test for each knowledge stream you wish to challenge. This will help you determine whether your current skills will enable you to succeed in the Challenge Exam(s).

Step 3: Apply to Sheridan's Computer Systems Technology advanced diploma program

Apply to the Computer Systems Technology – Software Development and Network Engineering program .

To be eligible to complete Challenge Exams for this program, you must select "Advanced Entry" as the level of the program on your application.

Step 4: Follow the instructions to complete your Challenge Exam(s)

Once Sheridan receives your application, we’ll send you an email with instructions on how to register and pay for your Challenge Exam(s). Follow those instructions.

Once you’ve completed your Challenge Exam(s), subject matter experts in Sheridan’s Faculty of Applied Science and Technology will evaluate them within 10 business days. The Faculty will forward your results to the Office of the Registrar, and any approved credit transfers will be posted in your Credit Transfer centre. Exam feedback will not be provided.

Step 5: Accept your offer of admission and pay your program fees

If you receive an offer of admission to Sheridan, please follow the instructions to confirm your offer and pay your fees by the due dates indicated in order to reserve your spot in the program.

We wish you success in this process and look forward to seeing you at Sheridan!

Program Fees

Fees shown here are estimates only. Fees are in Canadian dollars and include tuition, health insurance and ancillary charges.

The fees shown here are for the 2024–2025 academic year, and are subject to change. The fees displayed are for the first two (2) academic semesters of study at Sheridan unless otherwise noted; fees for subsequent semesters are not reflected on this website.

Fees for Canadian students

Notes: Co-op students must pay an additional fee of $535 in the term prior to each co-op work term.

Fees for International students

Financial aid & awards.

Your education is a big investment, and we're here to help! Keep an eye on our Financial Aid & Awards page for regular updates, and check out these important links:

• Ontario Student Assistance Program (OSAP)
• Scholarships, awards and bursaries
• Work Study Assistance Program

International Entrance Scholarship

All new international students* beginning their full-time postsecondary studies (Year 1, Semester 1) in Spring 2024, Fall 2024 or Winter 2025 semesters will receive an entrance scholarship ranging from $1,000 to $3,000.

*ESL and programs with tuition reduction are excluded

To achieve the critical performance, students will have demonstrated the ability to:

• Develop, implement and maintain processes and Standard Operating Procedures to execute clinical research projects and to ensure alignment with principles of quality assurance in compliance with applicable regulatory frameworks and best practices.
• Obtain and maintain required ethical and regulatory approvals to ensure the protection and safety of clinical trial participants and the integrity of research data.
• Communicate and collaborate with relevant stakeholders to ensure every aspect of the study can be completed according to requirements.
• Accurately collect and verify, or oversee, the integrity of research data from acquisition to recording.
• Evaluate, recognize and respond to project-related challenges to proactively resolve issues, mitigate risks and improve quality of projects.
• Manage the operations of research projects to ensure compliance and timely and on-budget conduct.
• Participate in professional development activities to maintain up-to-date knowledge and awareness of current developments in order to meet compliance in a changing clinical research industry.
• Identify and apply strategies to support culturally competent research settings involving diverse communities including indigenous peoples in order to recognize and prioritize health equity.

Frequently Asked Questions

Labs & technology, financial planning certification, professional sales certificate, program transition, earn your masters degree, transfer opportunities, clinical placements, articulation agreements, educational philosophy.

Sheridan's Honours Bachelor of Interior Design curriculum and its delivery are designed to address current social issues pertinent to the design industry. This enables students to broaden their understanding of their place within the world.

Fundamental to the vision of the program is the balance of creative and conceptual thinking with the technical and business aspects of the profession. Courses follow a logical sequence with the degree of difficulty building vertically from first year to fourth year.

The various streams provide a range of design problems building in size and scope, from simple to complex in various design sectors. The curriculum builds on fundamental introductions that ensures a strong foundation for students to apply additional more complex learning and skills developed later in the program.

Studio projects are designed to mimic professional practice and require applied theory, creativity and strong technical knowledge. Curriculum is also connected horizontally across each semester to help support the learning in courses happening simultaneously. This demonstrates the inter-connected knowledge and skills required to practice in the industry.

The program provides many opportunities that expose students to practicing professionals and professional practice. Industry leaders and representatives from professional associations like ARIDO and IDC are invited into the classroom as jurors and guest speakers throughout the four years. The internship also provides professional design work experience for students before they enter their final year of study.

The curriculum is student-centric and designed to equip students with the skills that are required for entry-level design positions and advanced study. Manual skills such as drafting, drawing and model making are developed alongside digital skills using current software. Students are also well-versed in the applicable building codes and regulations required to practice in Ontario. Students are exposed to valuable research skills and encouraged to continue their learning past graduation.

Program goals

Sheridan's Honours Bachelor of Interior Design program aspires to:

• Develop confident, creative and critical thinkers that can solve a variety of problems thoughtfully, improving the quality of the built environment and protecting the health, safety and welfare of the public.
• Equip students with the tools to think independently and ethically to ensure technically, environmentally, and socially responsible decision-making.
• Deliver current and relevant curriculum that incorporates equity, diversity and inclusion. This encourages students to create spaces that foster inclusivity and look at design from various perspectives within diverse communities, involving numerous stakeholders.
• Inform students regarding the various facets of the profession, engaging them with designers and industry affiliates.
• Encourage continuous professional and personal growth, instilling a desire to contribute to the profession and society at large. The program encourages students to become active participants in the design community, become members of their local Association, write their NCIDQ exams, give back to the community and become progressive leaders in the profession.
• Prepare graduates for entry-level design positions, equipped with the required knowledge and skills for employment in the diverse design industry, ensuring they possess the body of knowledge necessary to respond to social and environmental issues, while designing interior spaces that are technically proficient, code-compliant, conceptually strong, sustainable and all-inclusive.
• Provide enhanced opportunities for students to pursue post-graduate studies, employment, research and/or further their academic studies and/or credentials.

Pathways from Athletic Therapy and Kinesiology

If you've graduated from a health-science degree other than athletic therapy or kinesiology, your application will be assessed on an individual basis.

Get your Osteopathy degree in less time

If you're a graduate of Sheridan's Athletic Therapy or Kinesiology degree program, you may be eligible to start in the second year of this program after completing three bridging courses.

This bridging program will be available in Spring/Summer 2024.

How to apply: Submit an application using the program code PBHSB .

Bridging courses (Spring/Summer Semester)

• OSTP 17927D: The Science of Osteopathy (3 credits)
• OSTP 14859: Theoretical Pathways to Osteopathy (5 credits)
• OSTP 16333: Practical Pathways to Osteopathy (1 credit)

Course exceptions

After successfully completing the assigned bridging courses, you'll be admitted into Year 2 (Semester 3) of our Osteopathy degree. In order to earn your Osteopathy degree, you'll need to complete all courses in the remaining three years of the program , with the following exceptions.

You will additionally take:

• Year 2: OSTP 11271D: Clinical Methodology (3 credits)
• Year 2: SCIE 22437D: Human Physiology for Allied Health (2 credits)
• Year 3: SCIE 31116D: Pathophysiology for Allied Health (3 credits)

You will not need to take:*

• SCIE 26661D: Pathophysiology 1 (3 credits)
• OSTP 24645D: Structure & Function 2 – Lower Cervicals, Thorax & Upper Extremity (3 credits)
• OSTP 22482D: Applied Clinical Practice 2 (1 credit)
• FLPL 21839D: Internship Prep (1 credit)
• SCIE 39622D: Pathophysiology 2 – Systemic Interactions (3 credits)
• RESE 37626D: Statistical Methods in Health Sciences (3 credits)
• RESE 42279D: Applied Research Methods for Health Sciences (3 credits)
• BUSM 44956D: Business Entrepreneurship for Clinical Practitioners (3 credits)
• 6 Degree Breadth Electives (3 credits each)

*Athletic Therapy graduates are also exempt from the following course:

• OSTP 20782D: Clinical Experience 2 (0.5 credits)

Program Mission

Our mission is to utilize harmonious, comprehensive and specialized training to empower our learners with the knowledge, skills and attitude required to demonstrate the Professional Competencies for Canadian Pharmacy Technicians at Entry to Practice.

Program Vision

Our vision is to graduate highly-skilled life-long learners who uphold professional integrity and promote quality and safety in practice.

Critical Performance Statement

Upon graduation, students in Sheridan’s Pharmacy Technician diploma program will have demonstrated the ability to pursue the career of pharmacy technician and to practice safely in a community or hospital while adhering to the scope of practice for pharmacy technicians.

Field Placements

Writer-in-residence program.

Each year, Sheridan’s Honours Bachelor of Creative Writing & Publishing (CW&P) program hosts a Writer-in-Residence. The 8-month residency is awarded to a writer who embodies the distinctiveness and dynamism of the & in our program name.

In addition to working on at least one specific writing project of their own during their tenure, the Writer-in-Residence is responsible for creative leadership, mentoring and public outreach in the area of creative writing and/or publishing.

How our Writer-in-Residence supports Sheridan students

Students in our CW&P program benefit from the work and mentorship of our Writer-in-Residence, who:

• shares their expertise and experience as a creative professional and working writer;
• performs public readings from their recently published work and/or current work-in-progress;
• organizes public lectures and/or workshops; and
• works with faculty to augment existing curriculum in the area of creative writing, publishing and/or creativity.

2024–25 Writer-in-Residence

Fiction writer, editor and poet Cassidy McFadzean is joining Sheridan as the 2024–25 CW&P Writer-in-Residence.

McFadzean was born in Regina, Saskatchewan, where she earned an MA from the University of Regina. She went on to earn an MFA in poetry from the University of Iowa, and an MFA in fiction from Brooklyn College, where she was co-Editor-in-Chief and Fiction Editor of The Brooklyn Review .

McFadzean is the author of three books of poetry: Crying Dress (House of Anansi, 2024), Drolleries (McClelland & Stewart, 2019), and Hacker Packer (M&S, 2015). Her poetry has appeared in magazines across Canada and the U.S., has been anthologized in The Best Canadian Poetry , In Fine Form 2 , and The New Wascana Anthology . Her fiction has appeared in Joyland , EVENT , Maisonneuve , and The Best Canadian Stories , and is forthcoming in Hazlitt , The Walrus , and Invisible Publishing's collaborative anthology Dead Writers .

In welcoming her to the post, CW&P's Associate Dean Morgan Dennis highlights McFadzean’s expertise in both poetry and fiction, as well as her editorial work at The Brooklyn Review : “McFadzean is such a well-rounded talent, which is exactly what our students are looking for. Plus, her experience in the literary journal market will be of great value to our in-house magazine— The Ampersand Review of Writing & Publishing ."

Free professional development opportunities

Are you a business lead who's looking to level up your company's culture of creativity and entrepreneurship?

Sheridan offers FREE, one-hour PD sessions on topics such as:

• Creative Strategies for an EDI-driven World
• The Science of Creativity and Innovation
• Intra- and Entrepreneurial Thinking, and
• Creative Team Leadership

These workshops will catalyze your climate of innovation and give your team an exclusive look into Sheridan's one-of-a-kind graduate certificate in Applied Creativity and Innovation.*

Register your team for a FREE online one-hour masterclass!

*Advance further with our Applied Creativity and Innovation graduate certificate

Our new graduate certificate in Applied Creativity and Innovation is a great professional development (PD) opportunity for many company teams. The program teaches complex problem-solving, creativity, innovation and negotiation skills — competencies that make companies  more resilient and adaptable as they face the unique challenges presented by the future of work.

Why this program is a great choice for PD:

• Flexible hours — your employees can complete their graduate certificate online, at their own pace.
• Relevant coursework – they can choose electives that are most applicable to their position at your company.
• Award-winning faculty – they’ll learn from instructors who are on the cutting-edge of creativity and innovation research.
• Practicum project – they’ll work alongside our team of experts to resolve an issue that your business is facing today — whether it’s how to leverage artificial intelligence technology, advance your sustainability efforts, update your marketing strategies, address supply chain inefficiencies or another challenge.

Apprenticeship Exemption Test

The Apprenticeship Exemption Test (AET) provides a chance for students who are learning a skilled trade to bypass in-class studies.

In most cases, you need to score 70% or higher to pass the AET. If you score lower than 70%, you'll need to wait three months before you can try again (with some exceptions for certain exams).

Apprenticeship Exemption Tests are administered at the Hazel McCallion Campus in Mississauga, through Sheridan's Assessment Centre.

Learn more about the AET, including eligibility criteria, available tests and how to register.

Sheridan is a Ministry-approved Apprenticeship Exemption Test centre, authorized through the Ministry of Labour, Immigration, Training & Skills Development (MLITSD), for both apprentices and non-apprentices.

Program availability

Full-time 1 year Program code: PCRSH

Get a feel for your future

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You might also be interested in:

Honours Bachelor of Applied Health Sciences – Athletic Therapy

Honours baccalaureate degree 4 years.

Gain skills and experience to become a certified athletic therapist.

Clinical Kinesiology

Ontario college graduate certificate 1 year.

Get experience applying kinesiology skills in a clinical environment.

Not sure which program to take?

In 5 easy steps, discover your career preferences — then find programs that could be a great fit!

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Certificate in Clinical Research

Drive the next generation of treatments and therapies

On this page

• Register to a specific offering
• Program information

Next Enrolment

September 23rd, January 20th

Delivery Format

Blended (Online + Live Online Classes)

$6,594 (Domestic)

Program Length

Select an Offering to Register

Sep 23, 24 - Jul 20, 25

Program Type

Course Descriptions and Schedule

Cscr1000 principles of clinical trials, research & drug development.

This introductory course will orient you to the drug development process and the clinical research function. Pharmaceutical drug development will be used as a model, with some exposure to the development of devices and biologics. Basic concepts in clinical research, such as trial designs, trial phases, randomization, and blinding, will be discussed. By the end of the course, you will have developed a high-level overview of all phases of drug development and be able to explain the key components and principles governing clinical trial execution.

September 23 to November 03, 2024

Classes Sat,Sun 9:00 AM-12:00 PM (12 Oct 2024 to 13 Oct 2024); Sat,Sun 9:00 AM-12:00 PM (02 Nov 2024 to 03 Nov 2024)

CSCR1010 Regulatory & Ethical Issues in Clinical Trials

In this course, you will be familiarized with the regulations and ethical principles that govern the conduct of research, as well as their practical application in clinical trials. Following the presentation of the historical rationale for regulatory oversight, you will gain familiarity with the definitions and terminology used in laws directing clinical trials, as well as the national and international guidelines that apply to clinical research. By the end of the course, you will possess a strong understanding of the key ethical principles underlying ICH-GCP and their application in clinical research.

November 04 to December 15, 2024

Classes Sat,Sun 9:00 AM-12:00 PM (23 Nov 2024 to 24 Nov 2024); Sat,Sun 9:00 AM-12:00 PM (07 Dec 2024 to 08 Dec 2024)

CSCR1020 Clinical Trial Design & Planning

This course will provide you with sound knowledge of key clinical trial design principles, including how to design a protocol and other important aspects of conducting a clinical trial. Today’s healthcare industry is focused on following science, and on designing studies that answer important questions that advance the practice of medicine. This course has been developed to help you effectively navigate important decisions typically faced by clinical researchers when designing and planning clinical studies.

January 06 to February 16, 2025

Classes Sat,Sun 9:00 AM-12:00 PM (25 Jan 2025 to 26 Jan 2025); Sat,Sun 9:00 AM-12:00 PM (15 Feb 2025 to 16 Feb 2025)

CSCR1030 Clinical Research Operations

We will focus on the day-to-day operations of leading a clinical trial. You will gain applied knowledge in financial management, essential documents, recruitment, data management and strategies for safety reporting. Upon completion, you will possess the necessarily skills needed to effectively and efficiently execute clinical research trials.

February 24 to April 20, 2025

Classes Sat,Sun 9:00 AM-12:00 PM (08 Mar 2025 to 09 Mar 2025); Sat,Sun 9:00 AM-12:00 PM (29 Mar 2025 to 30 Mar 2025)

CSCR1040 Clinical Trial Monitoring

We will examine oversight mechanisms in clinical research operations, including monitoring, audits, and inspections, as well as safety, medical, and data oversight. The primary aim of this course is to empower you with the knowledge and practical skill sets required for end-to-end monitoring activities. You will gain valuable knowledge of monitoring practices which are essential to clinical trial conduct and management.

April 28 to June 08, 2025

Classes Sat,Sun 9:00 AM-12:00 PM (24 May 2025 to 25 May 2025); Sat,Sun 9:00 AM-12:00 PM (07 Jun 2025 to 08 Jun 2025)

CSCR1050 Clinical Research Capstone

After the completion of the first five courses and their applied learning assignments, this course is intended to further simulate real-world experience by combining all previous learnings to an applied clinical research management simulation. You will leverage all your knowledge, assignments and experiences to date to further develop your competencies in critical thinking and problem solving, teamwork and collaboration, as well as agility and adaptability, to ensure the successful execution of clinical trials. By taking your hands-on experience to the next level, you will be ready to begin work in the field and add immediate value to any clinical research team.

June 09 to July 20, 2025

Classes Sat,Sun 9:00 AM-12:00 PM (05 Jul 2025 to 06 Jul 2025); Sat,Sun 9:00 AM-12:00 PM (19 Jul 2025 to 20 Jul 2025)

Winter 2025

Jan 20 - Nov 02, 25

Blended (On Campus and Online)

January 20 to March 02, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (08 Feb 2025 to 09 Feb 2025)

March 10 to April 20, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (05 Apr 2025 to 06 Apr 2025)

April 21 to June 01, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (10 May 2025 to 11 May 2025)

June 09 to August 03, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (12 Jul 2025 to 13 Jul 2025)

August 11 to September 21, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (20 Sep 2025 to 21 Sep 2025)

September 22 to November 02, 2025

Classes Sat,Sun 9:00 AM-4:00 PM (18 Oct 2025 to 19 Oct 2025)

Become an essential member of the clinical research process by learning how to protect patient safety, ensure trial integrity, and manage adherence to research ethics, best practices, and regulations.

What you will learn.

In our part-time Certificate in Clinical Research, you’ll prepare for a career on the cutting edge of this field with instruction from leaders in clinical research who bring a practical perspective to the curriculum. This program will help you:

• Understand the stages  in setting up clinical trials
• Plan, manage, and monitor  clinical research and trials
• Adhere to good clinical practice including patient  consent, privacy, and data integrity protocols
• Abide by regulations and legislation to ensure that trials are  conducted ethically  while upholding scientific research principles
• Demonstrate accuracy and reliability  in data collection, management, and analysis

Program Benefits

• Practice applying clinical trial procedures, regulations, and best practices through  experiential assignments, projects, and case studies
• Advance through the program with the same cohort of peers, allowing you to  develop a strong professional network
• Apply your learnings in an  applied clinical research management simulation
• Balance your commitments with our  blended study option  which combines live classes with asynchronous online learning
• Complete the program faster  by earning your certificate in only nine months
• Careers in Clinical Research with Instructor Taymour Bibi [01:02:37]  [ Watch Now ] Find out more about this dynamic program and the emerging careers in the Clinical Research field. *From 00:23:10 – Instructor Taymour Bibi speaks about the careers in Clinical Research
• Opportunities and Challenges for Clinical Research Post COVID-19 [00:55:08]  [ Watch Now ] * From 00:19:25 – Instructor Miran Kenk speaks about COVID-19  fundamentally changing medicine in Canada and around the world, drastically altering how we conduct clinical research.

Career Potential

Canada is a World Leader in Clinical Research Canada currently ranks fourth in the world for number of clinical trial sites. The volume and growth of clinical trials taking place nationally signals promising job and career advancement opportunities.

The Need for Qualified, Confident Clinical Research Professionals is on the Rise The clinical research and trials industry has quickly entered a new phase, initiated and expedited by the COVID-19 pandemic. As the only university-level clinical research certificate program in the GTA, you will learn about the technological and operational changes this industry is undergoing firsthand.

Get Hired for Jobs Like:

• Clinical Research Assistant
• Clinical Research Associate
• Clinical Research Coordinator
• Clinical Trials Coordinator
• Clinical Study Specialist
• Clinical Project Associate
• Clinical Project Manager

Gain These Cross-Functional Skills:

• Relationship and stakeholder management
• Critical thinking and problem solving
• Teamwork and collaboration
• Agility and adaptability to a changing environment
• Patient interaction and interpersonal skills

Prospective students for this program include:

• Internationally Educated Medical Doctors (IMDs) and Internationally Educated Health Practitioners (IEHPs) who wish to meaningfully apply their existing skills and experience
• New graduates and early career professionals with a related degree who want to specialize their skills and experience in this growing industry
• Trained Nurses (RNs, RPNs) seeking opportunities for professional growth and advancement

Enrolment Requirements:

The Certificate in Clinical Research is a direct registration program. No application process is required; simply enrol in the session of your choice to get started.

Prerequisites:

Carefully review the prerequisites below to determine if the Certificate in Clinical Research is the right program for you. Individuals who wish to register for this program should have the following:

• University Degree in Health Sciences or a related degree in fields that can include—but not limited to—life sciences, biology, medicine, nursing, nutrition, physiology, anatomy, pharmacy, pharmacology, kinesiology, biochemistry, epidemiology, or health informatics

English Language Proficiency The metrics outlined below are recommended levels of competency:

If you have any questions about your eligibility for this program, please contact [email protected] and we would be happy to assist you.

Technology Requirements for Remote/Online Courses Please review the technology and software requirements you will need to access our courses remotely.

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Funding and payments.

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International Clinical Research Academy

– The CRA School –

Clinical Research Professionals Certification On-boarding Program

Access to clinical research regulatory affairs jobs.

Accredited Regulatory Training + 3 Internships + Coaching till Hired

Since 2009 we provide worldwide online clinical research certification & job placement support

Click here to see the latest news.

For safety reasons, face-to-face consultations are not offered anymore in the Academy since May 2020 (legal address only, no admission). For a FREE 1-hour 1-on-1 Career Consultation on your eligibility , CV adaptation, and Action Plan , suitable for you, contact us by email at [email protected] , by Skype at CRA School Montreal, or by phone from 9:00 AM to 9:00 PM EST (UCT-5), and by Skype chat – till midnight.

By phone : multilingual, 7/7 LIVE Support : + 1 (514) 257-3003 WhatsApp:  Support 7/7, till 9:00 PM EST : + 1 (514) 961-9351 Skype : by chat, 7/7, till 11:30 PM EST @ CRA School Montreal

To call at the right time, use this Time Zone converter

“An investment in knowledge always pays the best interest” .                                                                Benjamin Franklin

Education is the best investment , and to get a diploma in the comfort of your home became the new standard of learning . Already 12+ years the CRA School offers worldwide an Accredited Clinical Research Online Certification PG program with 3 remote internships in the Academy & 7/7 LIVE SUPPORT + Placement Assistance Till Hired to help students enter this ever-growing field. 1-on-1 courses for improving oral English or  French are provided by Skype on request 7/7 at additional, especially reduced fees for students. Vaccine trials created a huge demand for more staff. In the 2-nd year, most of our alumni are at $80,000/yr, and several are at rather high-level roles today. See them on LinkedIn.

You think that you know GCP ? Check do you know the GCP basics? *NB: This is not an admission test, the course is open to everybody

The Accredited Clinical Research Post-graduate Certification program CRP 3.0 covers the Canadian, US, and international GCP regulations for clinical trials conduct. It is designed to support till hired professionals in career change, newcomers and aspiring Canadian Permanent Residents, who plan to settle in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, and the Atlantic provinces, by preparing them in advance to get a job. The special fee reduction is our contribution to alleviating the pandemic burden.

The combined CRP 3.0 PG course prepares students not only for the CRA role, but also for almost all jobs in this field that don’t require a license to practice, including CRC , SSU, CTA , RA, DM , and even C PM , SSM, DSA , PHV, MSL , etc. It is internationally accredited by CPD UK and recognized by TransCelerate BioPharma USA as satisfying all the requirements for mutual recognition among clinical trials sponsors of GCP training courses .

Individual , self-paced , ONLINE program with unlimited 7/7 LIVE support, adapted to the goals of every student. A lot of home-based jobs, excellent for young mothers. Share the news with friends, who face career change , but lack the necessary tools & support, and get a $ 100 Referral bonus if anyone, whom you informed about us, enrolls someday

N.B.: If you plan moving to Canada, just join us 6-7 months before your flight and arrive JOB READY with a Canadian practical experience from the 3 internships, a Canadian diploma + a network of contacts + unlimited support till hired. This detailed ONLINE program allows to resolve the obstacle of the lacking Canadian experience, to arrive eligible for interviews, and get quickly a job. Share the news <more> .

* PATH to Clinical Trials Jobs for international graduates :

Clinical Trials are a great alternative for foreign-trained RN, MDs, BDS, DVM, PharmB/D, PhT & BSc/MSc/PhD degree holders. (No need for recognized diplomas , qualification exams , nor license to practice):

* Regulatory Affairs, Data QC/QA, Drug Safety & Pharmacovigilance Jobs

* Medical Affairs roles, high wages, fast access (4-6 months detailed self-paced training with 3 remote monitoring internships & 7/7 LIVE Support till hired)

*Most jobs became home-based today. Interesting possibilities for young mothers with babies. Frequent promotions due to the chronic 30% shortage of experienced staff. See more here

* Main obstacle to get into the industry :

The law requires regulatory training AND prior experience (at least from an internship ). We provide both + unlimited support till hired. Self-paced study with expected max. duration – up to 2 years. After that exams must be redone.

* What is different in CRP_3.0 :

To make students eligible for interviews, in parallel to the regulatory ICH GCP E6(R2) course, 3 remote part-time non-paid monitoring internships on old studies are provided in the Academy, plus:

+  active networking support to get job leads for the “ hidden jobs ” that are never posted, but filled-in by references,

+  unlimited assistance in the CV adaptation for every role + interview practice and preparation in advance (till hired).

* Who is eligible :

– Candidates worldwide with nursing or any university degrees – Research assistants, interested to join this rewarding industry – IMG in career change (MD, DDS, DVM, PharmD, BPharm, RN) – Clinical Nurses & CRC, looking to jump ships to the industry

* What you will get:

– International PG Diploma of Certified Clinical Research Professional (CRA, IH-CRA, CTA, CRC, DM, PM). All RA roles are covered

– “Hands-on” experience in Canadian/US regulatory environment from 3 monitoring internships, incl . Study Management Software

– Unlimited 7/7 support till midnight EST (UCT-5) from our tutors (NB: we are not a placement company, we assist you till hired)

* Who will profit to enroll:

IMG (RN/MD/DDS/DVM/PharmD/BPharm/MSc/PhD) and any life-sciences graduates worldwide. (No study permit needed. Private studies, not funded by government. Remote 100% ONLINE course, does not provide student’s visa support).

* Demo Chapter 12, Informed consent

Click here:  >>>, global accessibility program (gap).

. In the frame of the Global Accessibility Program ( GAP ) an additional regional discount is offered for some low-income countries in Africa, Asia and Latin America 

To enroll , interested candidates must send their CV with their current home address and their official names as per their ID to < [email protected]> to verify their eligibility for the GAP program and to send them a payment invoice .

The concept of our program is totally different. Self-paced individual ( not in a group), starts on the day of enrolling. Provided worldwide, 100% ONLINE course, with 7/7 direct contact with a tutor from 9.00 AM till midnight EST (UCT-5). This flexibility allows to study while working full-time.

The 3 remote part-time monitoring internships are done in 3 Phase II, III & IV studies on metabolic syndrome, LDL-C and diabetes in the Academy, in parallel to the GCP course and have a duration of 6 months or more. Support till hired. .

*                  FREE 1-ON-1 CONSULTATIONS                 *

Do you want to work in clinical research in Canada or

to move to Canada? Are there jobs available? How are

they paid? Are you eligible for them? Where to start?

Do I fit? You probably have hundreds of questions.

For a FREE 1-hour LIVE consultation, just s ay “Hi” by

Skype to our account “CRA SCHOOL MONTREAL” or

book a time spot 7 days/week here . Reserve 1 hour time.

Get answers to all your questions directly by our expert

Discuss in detail the amazing careers opportunities

in t he rewarding and booming clinical trials industry

and what Action Plan would be suitable for you.

To book a FREE 1-hour 1-on-1 Career Consultation

on your eligibility , CV adaptation and an Action Plan ,

suitable for you, click here

Well-known fact: Nurses make great Clinical Research Coordinators ( CRC ) and Clinical Research Associates / Monitors ( CRA ). They are preferred for CRC & CRA roles, and plenty of other roles too, because they know the principles of ethical clinical practice, the medical terminology, physiology and pathology, diseases and treatments, and how clinics operate.

In Regulatory Affairs ( RA ), no medical acts are performed, therefore no license to practice in the country is required. Work with data and documents, organization and control of clinical trials. Well paid jobs, no body fluids, no night shifts, no exams. A FAST TRACK road to the profession for foreign trained nurses.

The Accredited Postgraduate Program CRP3.0 provides not only GCP certification, but also practical experience in the clinical trials related tasks, required by law, active support in building a network of contacts with hiring managers, assistance in CV adaptation for every role, plus unlimited interview preparation till hired. The concept is unique and not offered by other training providers.

Contact us for details on how to kick-start your clinical research career. Get 7/7 LIVE Support by an individual tutor till getting the first job in the rewarding clinical trials industry. Proof of qualification required at registration. Foreign diplomas accepted.

SPECIAL for foreign and Canadian nurses: CAN $100 off regular (non-GAP) fee with the code ICRANURSES

To apply, email your CV to [email protected] to assess your eligibility, and to suggest you a suitable Action Plan .

Become an Affiliate: just share the info with friend

With the chronic 30% shortage of experienced staff, some 80-90% of the jobs are never posted (especially the entry level jobs), but filled-in by internal promotions and references. Companies pay a referral bonus of $1,000 up to $2,000 if they hire the candidate that you referred. Their employees are interested to bring your CV to the hiring manager, but they don’t know you. Hence the need to network. As jobs are “hidden”, candidates don’t see them and these rewarding well-paid Regulatory Affairs jobs in the booming clinical trials industry are widely unknown. Don’t hesitate to share this info with friends, who may profit from this opportunity.

. Refer a friend and get a Referral Bonus of $75 ($50 for GAP) .

Inform friends & colleagues about  these highly-paid careers in chronic shortage of staff, our free monthly Career Events, and our Clinical Research PG Diploma On-boarding program with 3 internships and Placement Support till Hired (PATH), and get a $ 75 referral bonus for anyone who eventually enrolls in the program.

To register a Referral, email us the names and email addresses of the person whom you informed . 

Bonuses are paid at the beginning of the month after the candidate enrolled. The number referrals is unlimited, don’t hesitate to spread the news.

. Electronic Data Capture (EDC) & Clinical Trial Management Software (CTMS) training and internship are an integral part of the CRP3.0 Post-Graduate program. This is a major hiring requirement. It is capital to have such practical experience.

Vaccine trials hasten the need for new clinical sites & staff. They need 40,000+ participants, 10 times more than drugs. This means a lot of new staff to handle this huge workload.

There have never been that many new jobs in this field. It is the best time to go to this rewarding & blooming industry.

The CRC, CTA, & In-house CRA roles are great entry-doors to the clinical trials field as they don’t need much prior experience

The demand of experienced staff is always high & will only grow. Share the information with friends, who will fit and can profit.

Clinical Trials Monitoring Workshop, Nov.19, Sat, 9:00 AM EST

Dec 26, 2022

All you need to know about the clinical trials monitoring visits and CRA role, presented by Ken Boudrault, SrCRA2 and mentor with 27 years of experence

Meet our Clinical Research Mentors series starts now

Aug 28, 2022

Ask all your questions regarding clinical research, monitoring, clinical studies, clinical trials, careers opportunities and how to get-in the industry to Dr Anna Leonov, Clinical Operations Specialist in Syneos Health.

Comprehensive Review of Clinical Research on CircRNA role in glucose metabolism in Cancer

Jun 26, 2022

Comprehensive review of Clinical Research studies findings on the CircRNA role in glucose metabolism in Cancer

Getting a clinical research job in Quebec, Canada – challenges and preparation in advance

Jun 20, 2022

The requirement of speaking French is blocking the way for foreign-trained candidates, who for family reasons or other considerations decide to settle in Quebec. The article suggest how to issue in advance to be ready for applying immediately after arrival for clinical research roles and avoid delaying your access to these rewarding jobs.

To enroll with CRA School Montreal, please fill-in the application form by clicking on the ‘Enroll Today’ button.

405 Avenue Ogilvy, unit #101

Montreal, QC, Canada H3N 1M3

(legal address, no admission)

[email protected] Information : +1 (514) 534-0273 Support 7/7 : +1 (514) 257-3003 By Skype: CRA School Montreal

• © 2009 - 2024 CRA-School - International, All Rights Reserved.

Clinical Research Associate

Clinical Research Associate Certification

Demo Clinical Research Associate Certification

CRA Training

CCRPS CRA Graduates obtained many job roles including:

Clinical Research Associate, Clinical Trial Monitor II, Research Associate, CRA II, Scientist, Quality Assurance Analyst, Senior Clinical Research Associate, Research Associate in Discovery Immunology, Clinical Trial Monitor/CRA, Clinical Trials Project Manager, Associate Director of Research Nursing, Clinical Trial Navigator, Clinical Director for R&D, Senior Clinical Research Associate, Clinical Research Professional, Medical Science Liaison, Clinical Trial Associate III, Quality Assurance Associate II, IRB/SRC Analyst II, Project Manager, Clinical Trial Associate, Clinical Research Coordinator, Public Health Advisor, Associate Scientist II, Strategy Analyst, Clinical Research Associate II, Clinical Operations Specialist, Advisor - Development Clinical Research Scientist, Neuroscience, Associate Clinical Engineer, Clinical Trial Management Associate, Quality Supervisor, Clinical Research Data Coordinator (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Associate Training

Advanced clinical research associate certification (acrac), introduction.

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

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

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

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

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

View CCRPS Clinical Research Associate Graduate Case Studies April 2024

Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek  ( view full case study )

Case Summary:  Marta Marszalek completed the  CRA certification course seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.  Marta appreciated the self-assessment opportunities, which helped identify areas that needed review. Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities,  affirming the practical benefits of the course. 

From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” -  Aishwarya Sukumar  ( view full case study )

Case Summary:   Aishwarya Sukumar completed the CCRPS CRA certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad.   Chose the CCRPS program for its  affordability and flexibility , crucial as she was adjusting to new motherhood and transitioning careers in a new country . Successfully transitioned from a CRC to a Lead CRC, and then to a CRA role , underscoring the significant career advancement facilitated by the course.  The course facilitated a  smooth transition into the clinical research field in the U.S. , providing her with necessary certifications and boosting her credibility in job interviews.

  From IMG to securing roles as a CRC, CRA, and now a project manager:  “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak  ( view full case study )

Case Summary:   Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS CRA training.  She secured positions as a Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.  The courses  provided her with essential knowledge and confidence, particularly in job interviews , by familiarizing her with industry-specific terminology and documentation. Dr. Borawake highlighted the c ourse's effectiveness for international medical professionals  seeking to enter the clinical research field in Germany or other countries, noting its comprehensive coverage of relevant regulations and practical applications .

From Masters in Health Safety to Clinical Research Associate:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

Case Summary:  Ossai appreciated the straightforward,  easy-to-follow video presentations  and found the sample questions at the end of each module particularly useful for reinforcing learning.  He found the roles and connections between CROs and CPIs most engaging and informative, providing  clear insights into the clinical research operation landscape . Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials  from other learners. The course equipped Ossai with the necessary skills and knowledge to transition into clinical research, enhancing his understanding of industry standards and practices.

From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish. Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

Case Summary:   Before CCRPS, Hannah Fischer Was A Grant Manager having difficulties with Clinical Trial Coordination . After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications. T he certification and the knowledge gained from  the course played a crucial role in Hannah securing a promotion at work , illustrating the career enhancement potential of the program. The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.  Hannah  actively recommended the CCRPS program to her colleagues, emphasizing its thorough approach to explaining the clinical trial process from start to finish.  Her endorsements highlight the program’s applicability and value across her professional network.

Enroll Schedule Advising

CCRPS Reviews

Cra certification, detailed information, oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

Amazing all inclusive course

David narouz.

The test was ever hard, I have studied and passed the CRA in 1 month of intensive study and would encourage anyone to take it.

Extremely well presented CRA course!

Abiodun babayeju.

This course is detailed, well presented, and provides all you need to become a confident CRA!

Fantastic tool to expand my CV

Marquise jeffery, kenny adazie, my thoughts, tondor cleopatra uzosike.

A very educative Course. Highly recommended

It is an excellent presentation with good speed in clear...

Cynthia zhao, patient recruiting and retaining, lynda agboola.

not too long but precise

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Subhash Soni

Good to understand, temitope oshineye, accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Remarkabley accurate lectures that go into so many reason...

Vaishnav nath ajeendra nath.

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...

ACRA Training

Ossai a opene.

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get int...

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get into the CRA space.

Gertrude Nenanya

Detailed and Informative. A lot to take in yet rich with step-by-step information to prepare anyone new to clinical research

clinical research associate

Khalel imanbayev, sathya ramamoorthy, best way to start a new career as an img.

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career ch...

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career change and honestly everything made sense so I felt like I really understand and enjoyed the material! You don’t need a science background to take this.

Knowledgeable

Norah okafor.

It has really been of great impact with my 5 years experience as a CRC.

Very good content

Great course for updating information and knowledge

Mohammad ismail, dr. jennifer campbell-allman, dr. jennifer campbell-allman, phd. msc., rmhci., very detailed information, goliath sakala.

This course is very detailed and informative.

Only resource CRAs need

Husnain arshad.

Very interesting and useful for CRA training

Advance Clinical Research Associate

Charity oparah, acrac review, cyprian suh.

Very, very enriching; content and presentation.

It is informative

Safeyeh alghazali, adeyinka balogun agesin, its a great opportunity for me to review again all aspect..., adam friday.

EXCELLENT EXPERIENCE

Loving my training!

Corinthia mims.

I really appreciate the ability to return to a section to observe again. I like being able to take my time to learn.

Sergiy Ivashchenko

Very Good Course

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.

Continuing Education

Applied clinical research.

Your key to entering the rewarding field of clinical research

Applied Clinical Research Program

Earn a certificate with online learning that fits your life.

Affiliated with the Faculty of Health Sciences , the Applied Clinical Research program is designed for individuals seeking to enter the field of clinical research.

• Program content is based on knowledge and skills for clinical research associates and managers as identified by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA)
• Maximize your potential and gain practical experience by applying your knowledge and skills through the clinical research capstone
• Taught by industry experts to help you gain the skills you need for success in applied clinical research

Information Box Group

Program highlights Learn More

• Theory and practical experience
• Taught by industry experts
• Learn in-demand skills and advance your career with convenient, flexible online learning that fits your life

Applied Clinical Research program features:

• Job ready skills in clinical research principles, ethics, regulations, project management, data management, and pharmacovigilance in relation to clinical operations
• A culminating applied capstone that will enable to you to enhance your resume
• Convenient online courses to fit your life

What you'll learn Learn More

• The principles of Good Clinical Practice (GCP)
• Regulatory, legal and ethical research practices
• Strategies for good clinical trial management

Through our Applied Clinical Research program, you’ll learn to:

• Describe Good Clinical Practice (GCP) requirements and legal and regulatory issues in clinical research
• Construct a clinical research protocol
• Differentiate key elements of successful study and site management
• Examine ethical issues in clinical research and select appropriate strategies
• Practice the leadership and communication skills needed in clinical research
• Demonstrate an awareness of ethical practices and professional standards applicable for clinical research
• Effectively communicate with the various stakeholder groups engaged in clinical trials
• Demonstrate personal management, leadership and project management skills

Learn more about the Applied Clinical Research program

Who should take this program.

The Applied Clinical Research program provides a solid introduction to the varied areas of knowledge and skills related to clinical research. The program is intended for individuals seeking to enter the field or professionals upgrading knowledge and skills.

What are the career opportunities?

Earning a Certificate in Applied Clinical Research opens doors to wide range of rewarding careers such as:

• Study Coordinator
• Ethics Coordinator
• Clinical Data Coordinator
• Clinical Data Management Associate/Specialist
• Project Coordinator
• Clinical Trial Assistant
• Clinical Research Associate (Junior)
• Clinical Research Assistant
• Clinical Research Coordinator

Upon completion of the program it is recommended that you consider obtaining a professional designation from ACRP or SOCRA.  By considering your background and future career goals you will find a professional designation that best suits your needs.

Academic Learning Outcomes

Upon completion of the program, learners will be able to:

• Summarize clinical research principles and study design concepts
• Identify the sequential steps, milestones, processes, and deliverables for conducting a clinical trial across a study’s start-up, maintenance, and close-out phases
• Describe study conduct in compliance with clinical research protocol requirements, as well as good clinical practice (GCP) guidelines, standard operating procedures (SOPs), research ethics board (REB) requirements, and federal regulations (Health Canada and FDA)
• Create study documents and forms that are essential for clinical trial conduct
• Explain how quality management processes are implemented in clinical trials to ensure participant safety and data integrity
• Apply core principles when examining ethical issues in clinical research
• Demonstrate teamwork, leadership, communication, and project management skills needed to work effectively with multidisciplinary study teams

Association of Clinal Research Professionals (ACRP)

ACRP: Association of Clinal Research Professionals

Program content is based on knowledge and skills for clinical research associates and managers as identified by the Association of Clinical Research Professionals (ACRP)

There are 6 designations at the ACRP , we encourage you to explore these opportunities to determine which would best align with your interests and background. Contact ACRP for more information.

Society of Clinical Research Associates (SOCRA)

SOCRA: The Society of Clinical Research Associates

Students completing the Applied Clinical Research program with McMaster Continuing Education could qualify for the  SOCRA certification under Category 3 as long as they meet all requirements. Candidate eligibility for the SOCRA certification can only be assessed by SOCRA according to SOCRA full list of requirements. Acceptance is not guaranteed and it is up to SOCRA’s discretion to accept candidates after reviewing candidate’s profile. If you have a question about Candidate eligibility please email SOCRA at [email protected].

Consortium of Academic Programs in Clinical Research (CoAPCR)

CoARCR: Consortium of Academic Programs in Clinical Research

The Consortium of Academic Programs in Clinical Research (CoAPCR) facilitates the development of high-quality educational programs encompassing all areas of clinical research that are based in academic credit-granting institutions.

McMaster’s affiliation with the CoAPCR provides a medium for communication among educators, institutions, and industry

The Canadian Society of Respiratory Therapists (CSRT)

This educational offering has been approved for the following continuing education credit/professional development credit by the Canadian Society of Respiratory Therapists . McMaster University Continuing Education maintains all responsibility for this offering and its content.

ACR 101: Principles of Clinical Research (36 credits) ACR 102: Research Ethics (39 credits) ACR 103: Clinical Trial Design (39 credits) ACR 104: Clinical Trial Management (39 credits) ACR 105: Clinical Research Capstone (36 credits)

ElevateYourSkills option for McMaster undergraduate students

Are you a current McMaster University undergraduate student?

Explore the ElevateYourSkills option to learn how you can earn an Applied Clinical Research certificate as part of your degree.

• Use your electives to earn a professional certificate or diploma
• Fully online courses that you can fit into your schedule
• Providing you with real-life career skills and experience before you graduate

Learn more here.

Check out our latest Health Program Preview video to learn more about the Applied Clinical Research program

What our recent graduates say

I wanted to reinvent myself and change my career path and I was able to do that.

Krystal Health and Social Service Skill Development graduate

I wanted to be able to reinvent myself and change my career path and I was able to do that because of McMaster Continuing Education. Being a nurse, there are so many different avenues of nursing that I can try new things and continue to learn. The instructors were really understanding. When you’re working full-time, having someone that will promptly answer your questions and make time for you when you need it, they made it really easy.

Health and Social Service Skill Development graduate

Other programs you may be interested in

Health information fundamentals program, nutrition, health and wellness program, health and wellness coaching program, applied clinical research certificate, certificate in applied clinical research, earn your certificate in applied clinical research with mcmaster continuing education.

Explore the requirements below and register today!

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Certificate in applied clinical research learn more.

Earn the Certificate in Applied Clinical Research by completing all 5 courses listed below.

Certificate in Applied Clinical Research Requirements

Academic Credit – 15 Units

Admission requirement: A completed post-secondary education (diploma or degree) is strongly recommended.

Students are given a three-year period to complete all required components of the certificate program. This requirement is based on the need to remain current with legal, regulatory and ethical considerations in the field of work.

Note: Courses must be taken in the following order:

• Principles of Clinical Research
• Research Ethics
• Clinical Trial Design
• Clinical Trial Management
• Clinical Research Capstone

Courses (complete all 5)

Acr 101 principles of clinical research, acr 102 research ethics, acr 103 clinical trial design, acr 104 clinical trial management, acr 105 clinical research capstone, applied clinical research schedule.

This schedule table displays courses planned to be offered this year and is a guide to planning your courses for the academic year. Please note: Spring term registration opens mid-March and Fall/Winter term registration opens mid-July.

For more information about our learning formats and to choose a format that works best for you, please visit our Learning Formats page. All times listed below are in the Eastern Time Zone (ET).

The schedule table is subject to change. Please visit the course pages to browse classes currently available for registration and the latest cost information.

Admission Requirements

This program is open enrolment, which means there is no formal application or admission procedure. To enrol in a course, simply register online. Our courses can be taken as part of a program or individually.

To enrol in McMaster Continuing Education programs, you must:

• Have an Ontario Secondary School Diploma or equivalent
• Be a mature student as defined in the Undergraduate Calendar of McMaster University or
• Be deemed an exceptional case

To ensure you are successful in your online courses, you are required to have knowledge and skills with general computer applications, such as keyboarding, file management, video conferencing and word processing.

Language Requirements

If your first language is not English, you must meet the  University’s English language proficiency requirements . Completion of TOEFL exam with a minimum acceptable score of 20 on each of the four components (reading, writing, speaking and listening), valid for 2 years.

Expandable List

How to register for our courses and programs.

• Visit continuing.mcmaster.ca/programs  to find your program of choice
• Click on each tab on the program page to learn about credential options and requirements, schedule and fees, and a list of all courses in the program
• Select a course and then select an available offering, noting important information such as cost, delivery format , and start/end dates; then click ‘add to cart’
• Once you have added your courses, click the shopping cart icon at the top right-hand corner of the page (bottom of the browser screen on mobile)
• Review your cart and, once you’re ready to proceed with enrolment, click ‘proceed to checkout’
• As the next step, you will be redirected to Mosaic – McMaster’s Administrative Information and Enrolment system
• Once you are in Mosaic, select ‘new to McMaster’ or log in with your existing MacID and password (if applicable)
• Complete all required fields and select a program of study when prompted (i.e., a specific program or open studies for standalone courses)
• Finally, payment is required in full to secure a spot in your course(s)

A payment receipt email will be issued to you immediately after registering, and a course confirmation email will be sent to you overnight. Within approximately 24 hours of registering, you will also receive an important email containing credentials used to activate your MacID, which you must do before you can access courses in Avenue to Learn. Please review our  Getting Started  page to learn more about the next steps for beginning your studies after registration, and our Help Centre for our Refund Policy and other frequently asked questions. Please note that on average, each course requires 6-8 hours of study per week, per course (sometimes more) and some courses may have listed prerequisites. Please plan your schedule accordingly. Most students take 1-2 courses per term across a few different terms and a full-time equivalent course load is typically 3-4 courses per term.

For more information and a walkthrough on how to register, please check out this video.

Payment Options

• Payment must be made in full at the time of enrolment
• Online credit card or debit payments are preferred
• Accepted credit cards: Visa, MasterCard and American Express
• Accepted debit cards: Visa Debit and Debit Mastercard
• Google Pay is available for faster checkout
• Payments can be made from a Canadian Financial Institution and can take 2 to 4 business days to arrive in your McMaster student account. Once payment has arrived, you can register for your course. Please note that if the amount of the course fees owing is more than what was transferred to your student account, you will be dropped from the course.

Ready to get started?

Visit the Schedule tab to select your course and proceed with the registration steps.

•   About-Qtech  
• Certifications
• Clinical Research-Trials
• Drug Safety-Pharmacovigilance
• CLINICAL DATA MANAGEMENT
• Data Analytics And Reporting
• Check Best-Fit Program
• Resume Marketing Services
• New LMS Portal Login
• Old LMS Demo Login
• Old LMS Portal Login
• Old LMS Exercise Solutions
• Training Partnership
• Educational Alliance
• Client Partnering

CLINICAL RESEARCH ASSOCIATE

• Course Details

Clinical Research Associate

Qtech-Sol specializes in Clinical Science Training, offering a comprehensive program geared towards individuals aspiring to work as Clinical Research Associates (CRAs). Our course is meticulously structured to provide a strong foundation and practical skills necessary for these job roles.

The program places a strong emphasis on the pivotal role of CRAs in various aspects of clinical research, including protocol design, site initiation, trial conduct, ongoing monitoring, and effective management of clinical trial data capture and audits. Our curriculum is strategically crafted to provide students with a competitive advantage in securing employment opportunities as CRAs within the pharmaceutical, biotechnology, medical device, clinical research organizations (CROs), and research clinic sectors.

• Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
• Course Reading Material: Comprehensive chapters designed to facilitate an in-depth understanding of the subject matter.
• Practice Quizzes: A set of 15 quizzes to reinforce learning and assess your progress.
• Assessment Tests: Ten different test sets to evaluate your grasp of the material.
• Short Questions: Succinct questions to encourage critical thinking and quick recall.
• Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.

SIP – Self-Paced Online with Support

CRAT-SIP Delivery – 8 Weeks / 168 Hours (Self-Paced)

A Clinical Research Associate (CRA) plays a pivotal role in the management of clinical trials and studies associated with pharmaceutical and biotechnological products, medications, and medical procedures. Their responsibilities encompass a wide range of tasks, including:

• Participant Recruitment: Identifying and enrolling suitable study participants.
• Data Collection: Gathering and recording patient data in a meticulous manner.
• Study Documentation: Crafting and maintaining essential study documents.
• Quality Assurance Audits: Conducting thorough assessments to ensure adherence to study protocols and quality standards
• Report Compilation: Compiling and finalizing reports derived from extensive, long-term clinical trials.

In addition to these core functions, CRAs serve as a vital link between the study’s sponsor, often a pharmaceutical company or contract research organization (CRO), and the clinical sites where the research is conducted. This intermediary role is crucial in maintaining the transparency and integrity of clinical trial results, ensuring that they remain free from any undue influence or bias associated with the sponsor’s interests.

To excel in this role, a successful CRA must possess exceptional attention to detail, a high level of education, and the ability to communicate effectively with both sponsor representatives and clinical personnel. Their dedication to upholding the highest standards of research ethics and protocol adherence is paramount to the successful execution of clinical trials.

Qtech-Sol offers a flexible approach to learning through our self-paced online courses. Students have the freedom to commence their studies at their convenience, following a straightforward process.

• Member Registration: Begin by registering as a member of our platform
• Course Selection: Explore and choose the course that best suits your needs and goals.
• Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
• Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
• Support and Assistance: Receive support and assistance via email or schedule Google Meet sessions through the LMS.
• Course Task Submissions: Submit course-related tasks and assignments as per the provided schedule.
• Final Examination: Upon finishing the course, take the final examination to demonstrate your understanding.
• Course Completion: Upon successful completion, receive a course completion certificate and a transcript.
• Post-Training Support: Take advantage of our post-training support for assistance with resume building, narrative development, and mock interviews.

This step-by-step process ensures a smooth and flexible learning experience, allowing you to acquire valuable skills and knowledge at your own pace.

Clinical Research Associates (CRAs) are pivotal in the conduct of clinical trials, particularly within the pharmaceutical industry. Their core tasks and duties ensure that clinical trials are conducted, recorded, and reported per the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement. Here’s a detailed breakdown of the core tasks and duties performed by CRAs.

• Site Selection and Evaluation: CRAs are involved in the initial selection and evaluation of potential sites for clinical trials. They assess the site’s capabilities, the investigator’s qualifications, the staff’s expertise, and the site’s past performance to determine if it meets the study’s requirements.
• Site Initiation and Training: Once a site is selected, CRAs conduct initiation visits to train site staff on the study protocol, procedures, GCP, and specific regulatory requirements. They ensure that the site is fully prepared to begin enrolling patients and conducting the trial.
• Subject Recruitment and Informed Consent: CRAs monitor the recruitment process to ensure that it aligns with the protocol and ethical guidelines. They also ensure that informed consent is obtained from all participants in a manner that is compliant with regulatory and ethical standards.
• Monitoring Visits: One of the primary responsibilities of CRAs is to conduct regular monitoring visits to clinical trial sites. During these visits, they review and verify the accuracy and completeness of the patient data recorded in case report forms (CRFs) against source documents, ensure the trial is conducted according to the protocol and GCP, and verify that the rights and well-being of participants are protected.
• Safety Monitoring: CRAs monitor and report any adverse events or side effects experienced by participants to ensure the safety of the participants and the validity of the trial data.
• Data Quality and Integrity: They ensure the integrity and quality of the clinical trial data through regular monitoring, verification, and validation. CRAs address any data discrepancies and ensure that all data corrections are made according to the protocol and SOPs.
• Regulatory Compliance: CRAs ensure that all aspects of the trial are compliant with the regulatory requirements, including the submission of necessary documents to regulatory authorities and ensuring that the trial adheres to local regulations and guidelines.
• Communication and Coordination: They serve as the main communication link between the clinical trial site and the sponsor, addressing any issues that arise during the trial, and ensuring that there is a continuous exchange of information.
• Report Writing: CRAs are responsible for writing detailed reports following monitoring visits, highlighting their findings and actions taken during the visit.
• Problem-solving: They are often required to address and resolve any issues that arise during the trial, which may involve protocol deviations, non-compliance, or other challenges impacting the trial’s conduct or data quality.

Upon successful completion of our program, individuals can explore various job titles, including but not limited to:

• Clinical Research Associate (CRA)
• Clinical Research Coordinator (CRC)
• Clinical Trial Assistant (CTA)
• Research Associate (RA)
• Clinical Trial Management System Assistant (CTMS)
• Trial Master File Associate (TMF)

This comprehensive training equips aspiring professionals with the skills and knowledge needed to thrive in the dynamic field of clinical research.

Preferred Qualifications: A candidate with an associate or bachelor’s degree in life sciences or a related health field is highly recommended for admission into this course. Some of the eligible majors for enrollment include Medicine, Nursing, Pharmacy, Public Health, Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical Engineering, Pharmacology, Toxicology, and Healthcare Administration.

Your resume is often the first impression you make on recruiters and potential employers. In today’s competitive job market, it’s crucial to ensure that your resume meets industry standards and effectively represents your qualifications. That’s where our Post-Training Assistance (PTA) program comes in.

Our PTA program offers valuable assistance in resume building, interview preparation, and mock interviews. It’s not just about creating a strong resume; it’s also about understanding the current job market in your area, identifying available positions, gauging salary ranges, and ensuring that your resume aligns with your career goals. During the PTA program, you’ll have the opportunity to engage with our course specialists, taking small but meaningful steps toward your professional success. We’ll work together as a team to help you achieve your career objectives.

   Key Learning Outcomes and Benefits for Students:

• Enhancing the knowledge and skills required for your field.
• Improving your resume to increase your chances of landing promising job opportunities.
• High-value learning at an affordable cost.
• Flexibility to learn from anywhere, at your own pace.
• Practical tasks aligned with real-world industry practices and job roles.
• Application of concepts in real-time scenarios, including policies, governance, and industry tools.
• Engaging in role-based tasks commonly practiced in the industry.
• Preparation with mock interviews and interview narratives for effective client discussions.
• Readiness to work with minimal support, boosting your confidence in your chosen field.

Consider joining professional organizations and associations related to your field. These groups offer valuable networking opportunities, resources, and insights from fellow professionals. They can help you stay updated on industry trends and discover new career prospects.

Stay Informed:

Explore global clinical resource information to stay informed about the latest news and updates in areas like clinical trials, regulatory matters, clinical data management (CDM), and pharmacovigilance.

Our program has been meticulously crafted by industry experts to provide students and young professionals with the essential knowledge and skills needed to pursue careers in the field. It offers a comprehensive understanding of the roles and responsibilities associated with Clinical Research Associates (CRAs). The curriculum encompasses both theoretical and practical aspects of these roles, equipping students with the necessary expertise and exposure to meet industry standards.

For more information, please call us at +1 905.228.9698 / +1 905.519.0889 (WhatsApp) or email [email protected] . Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.

Clinical Research

Select start date and campus

• = Canadian Offering
• = International Offering
• AD = Accelerated Delivery
• Program description

Applying as a Canadian applicant

Domestic students should apply using a Conestoga College Program Application Form .

Applying as an International applicant

Campus tours.

Campus tours are one of the best ways to experience Conestoga. During this time, we are offering online guided tours to show you all Conestoga has to offer.

Virtual tours

If you can't make an on-campus tour or attend one of our events, the virtual tour is a great way to visit us.

Program description - October 2024

Conestoga's Clinical Research program will provide you with skills and knowledge to enter the competitive industry of clinical research by gaining hands-on work experience in our state-of-the-art facilities. Building on your science or healthcare knowledge, you will learn research design concepts, develop a foundational knowledge of data analysis, privacy and management, and ethical best practices to support quality clinical research. Throughout the program, you will familiarize yourself with clinical study protocols from pharmaceutical, cannabis, medical device, and natural health industries, as well as public health and epidemiology. The program's focus on artificial intelligence and novel diagnostic technologies such as genomic sequencing in clinical research, provides you the cutting-edge knowledge to help you gain a competitive advantage in the domain of clinical research.

Program details

Program contacts.

• [email protected]

Academic school

Health & Life Sciences

​Join one of our events to find out more about Conestoga. Connect with staff, current students, and future Condors to see how Conestoga is right for you.

Tuition & fees

Tuition and fee details for the 2024-2025 academic year (September to August) are listed below. Books and supplies may be additional.

International

Canadian fee details, returning student tuition & fees.

View all Canadian tuition & fee details for all levels View all International tuition & fee details for all levels

International fee details

Program device & software requirements

This program requires you to have a device that meets certain specifications. For most students, this cost is in addition to the tuition & fees listed above.

Financial assistance

Awards & scholarships.

Student Financial Services awarded more than 400 awards, scholarships and bursaries last year.

Search for awards .

Delivery sequence - October 2024 - Kitchener – Doon

• Guidance Counsellors
• International Agents

Clinical Research (CRQC)

Starts in January, May, September

Credential Awarded

• Admission requirements

Delivery:  At Seneca, courses are delivered in the following  formats : online, in-person, hybrid (an online, in-person combination) or flexible (offered in-person and online at the same time).

The chart below outlines the delivery options available for each course in this program. For some academic terms, there may be more than one delivery option available. You’ll be able to select your preferred options when building your course schedule during open enrolment.

Preferences  for course delivery will be considered on a first come, first served basis.

Work-Integrated Learning Term

Program Learning Outcomes

Learn more about program learning outcomes for this program.

Program of Study

2024/25 Academic Year (Current)

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Ensure Safety in Patient Care in Clinical Research

GRADUATE AS A

Clinical researcher (cr), in 52 weeks, program overview.

52-Week Clinical Researched Post-Graduate Diploma Program

Ready to make a major impact in the healthcare field? If you are passionate about clinical research and possess strong project management skills, excellent attention to detail and data analysis skills, you can build a rewarding career as a Clinical Research Graduate!

• Organize the collection, delivery, and storage of data taken during clinical trials
• Maintain the right testing environment that would allow for the development of new, potentially life-saving drugs or vaccines
• Overseeing large clinical trials, similar to managing big projects
• Deliver uncompromised data to regulatory authorities
• Educate doctors, nurses and patients about the trial
• Present your findings via research papers, presentations, and reports

Is a Career in Clinical Research Right for You? Take the 'Oxford College Clinical Research Career Training Readiness Quiz'

This fun, online quiz takes 3-minutes to complete and you’ll get a personalized report. Identify your strengths and social style plus the training and positions you’re best suited for. Get your Clinical Research Career Training Readiness score now!

Invaluable CR Skills

During the Clinical Research Diploma program, you will:

• Understand the basic ethics and professionalism in the healthcare environment
• Understand the stages of drug development from its discovery to get approval for human use.
• Know the phases of clinical trial research, the basis of useful design, several types of therapeutic trials and device trials
• Learn operational aspects of a clinical trial, from design to start-up, to close, statistical analysis and reporting
• Know the basics of clinical trial management
• Understanding the pathology of the illness or disease that is being researched, the rationale, pharmacokinetics and pharmacodynamics of the proposed treatment or therapy
• Procedure manuals, instruction sheets, standard operating procedures, patient data tables and charts

Many Unique Benefits

• Provides an extensive placement experience for practical, hands-on learning
• Our Program Lead is one of the leading experts in the industry
• Designated Career Services Coordinator with extensive background in Clinical Research placements
• Impressive facilities and the latest state-of-the-art equipment
• Access to the leading industries and big names
• Excellent placement opportunities (14 weeks)
• Unique curriculum of the Clinical Research Program
• Flexible hours
• Provision of Postgraduate Diploma

Why Choose Oxford College?

Career-focused education.

All of the diploma programs are designed for long-term careers in high-growth industries, offering you superior fast-track education

Expert Instructors

Our faculty consists of experienced and well-trained staff, who will give you industry-relevant knowledge along with your career training

Modern Facilities

The state-of-the-art classrooms and labs are compliant with industry standards and allow for an emphasis on practical training

Easy Campus Access

All our six campuses are located along transit hubs making travel easy and conveniences accessible.

Flexible Start Dates

Flexible program start dates allow you to plan and begin your new career training at any time

Financial Aid

Financial Aid may be available to those who qualify. We have dedicated staff who can assist you with the Financial Aid process

Be More Unstoppable. Get Your Free Laptop

Refer a friend to Oxford College to help propel their career!

If your friend is interested in following in your footsteps, you could be eligible for a $500 reward.

Refer a Friend Now!

Clinical Research 1-Year Postgraduate Diploma | $76,960 median annual salary *

• Graduates hired by government departments and agencies, research institutes, hospitals, pharmaceutical companies, and Contract Research Organizations (CROs)
• Clinical research professionals contribute to research studies that have major impacts on healthcare.
• Students will gain knowledge and experience in the designing, monitoring, and management of medical research, including clinical trials.

* https://www.jobbank.gc.ca

Message from the Program Coordinator

Dr. Kamyar Motavaze, Ph.D.

I am excited to welcome you to the Clinical Research Program at Oxford College. This is a terrific opportunity for graduates who have medical and healthcare-related backgrounds.

I encourage you to learn more about our Clinical Research Program and discover what makes Oxford College a great learning environment. We offer a unique curriculum and flexible hours for this program, and your three-month placement is guaranteed.

Flexible Program Options

Wish to start a new career but have conflicting priorities? Don’t worry, you’ve come to the right place.

At Oxford College, we offer flexible class schedules including Morning, Afternoon, Evening and Weekend sessions. We also offer flexible learning options (Online, Hybrid and In-person) for many of our programs.

For more information about Oxford College’s flexible program options, inquire today!

SEND ME THE DETAILS

Passionate Instructors! Quality Education!

Oxford College is proud of its highly skilled and experienced instructors. Each one of them is passionate about providing quality education and dedicated to helping you develop the skills you need to succeed in the workforce and attain a meaningful career.

Countless Career Opportunities

Oxford College Graduates are employed by government departments and agencies, consulting establishments, universities, research institutes, hospitals, pharmaceutical companies, contract research organizations, community agencies, professional associations, non-governmental organizations, and international organizations.

Upon completion of the program, you may find employment as:

• Clinical Research Assistant
• Clinical Research Coordinator
• Clinical Research Associate
• Clinical Research Project Leader
• Clinical Research Monitor
• Medical Information Associate
• Clinical Data Management Associate
• Data Analyst

Admission Requirements

BSc or Equivalent OR Allied Health Diploma

OR Pharmaceutical Diploma

I am glad that I came across Oxford College’s Clinical Research Program. The college has most programs with flexible schedule, perfect for working students or anyone who wants to study rom the comfort of home. My instructors Mr. Kamyar Motavaze and Mrs. Masoumeh Moshtaghi are not just educators, but mentors who genuinely care about their students’ success. They not only work on the academic knowledge but also help students in becoming a well-rounded individual ready to make a positive impact in the world. I highly recommend Oxford College to anyone seeking a comprehensive, supportive and enriching college experience. Afreen Sultana, Clinical Research Graduate

Personalized, Lifelong Career Counselling Services

At Oxford College, our support does not end after you graduate. Even after you earn your Diploma, our Career Service Advisors will continue working with you and help you build your career path together, for the long term.

Get Your Career Off To A Flying Start

Many people need extra  financial aid  to attend school. At Oxford College, we believe that finances should not be a barrier for anyone seeking higher education. That’s why we have many funding programs in place, including OSAP, Second Career, and private student loans, to name a few. We will also collaborate with you to set up manageable monthly payment plans. Sit down with a Financial Aid Advisor today. They will assess your situation. And create a funding plan that works for you.

Get More Info…

If you’re interested in learning more about Oxford College and exploring if this is the right career path for you, fill out the form  on this page to receive more information.

For immediate questions, call 1-866-604-5739

Clinical Research Certificate

The Clinical Research Certificate provides training in research methods for faculty members, postgraduate residents, international fellows and community-based health care professionals who want to improve their knowledge and skills in research methodology and quality improvement. Completion of the certificate will significantly enhance your ability to understand, effectively use, engage in and collaborate in research. It is not intended as a substitute for a research-based graduate degree, nor is it intended to lead to independent research projects (i.e., to take on a Principal Investigator role on large projects).

Program Objectives

After completing this certificate program, students will be better able to:

• Construct meaningful research questions applicable to primary care research
• Compare and describe qualitative and quantitative research methodologies
• Design and contrast quantitative and qualitative data collection and analysis procedures
• Appraise and critique data reported in the literature from research studies
• Identify, discuss and complete a grant proposal for submission to a research ethics board

Target Audience

Clinicians seeking greater expertise and confidence in the use of research in their practice

Applicants must be health care professionals licensed and in active practice in their country of primary residence.

As of 2021 term admission cycles, we will be considering applications from Internationally-trained Family Physicians or General Practitioners who are citizens or permanent residents of Canada and intending to re-position their careers with a research focus.

Program Length

This 4-module program can be completed within 8-12 months up to a maximum of 24 months.

Certificate

A Departmental Certificate of Completion will be issued by the Department of Family and Community Medicine, University of Toronto, to participants who satisfactorily complete the program.

Learners are evaluated on each component on a pass / fail basis. There is no terminal examination or thesis. All components must be passed.

Or contact us if you have any questions

Program Requirements

Required course.

Choose one(1) of:

• FD05: Research Issues in Family Medicine and Primary Care
• FD01: Appraising and Applying Evidence to Assist Clinical Decision-Making (online course)

Required Practicum

The practicum provides an opportunity for reflective hands-on practice of knowledge and skills in clinical research.

• FD91: Clinical Research Practicum

Two Elective Courses

The elective courses allow students to learn more about a relevant topic of clinical research.

Choose two from the following list:

• FD13: Leading Improvement in the Quality of Health Care for Community Populations
• FD16: Applied Survey Methods for Health Care Professionals
• FD18: Family Medicine and Interprofessional Primary Care in the Global Health Context
• FD23: Practical Management Concepts and Cases in Leading Small Health Organizations

For detailed course information and scheduling, please view our  course menu.

CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam., read the latest acrp ccra® blog, “spotlight on the clinical research associate career pathway and resources” >.

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants who meet one of the following criteria:

Hold an active acrp certification, have successfully completed a clinical research education program*, what qualifies as a clinical research education program*, must be aligned with the topics found in the corresponding detailed content outline (dco), must have a valid third-party accreditation, must provide applicants with knowledge that is equivalent to 1,500 hours of knowledge earned through employment, *program approval is at the discretion of acrp and will not be reviewed or pre-approved outside of a paid application..

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 10 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 24 hours..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

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Clinical Research Associate (CRA)

This role-based course provides the practical know-how to monitor clinical research sites effectively.

About this Course

A foundational course for individuals considering a career as a clinical research associate (CRA). The course provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, contract research organizations (CROs), clinical research coordinators (CRCs), and principal investigators.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Research Administrators, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations Independent Learner Price: $99 per person

Course Content

" role="button"> scientific concepts and research design.

This module explores how scientific principles inform study design and protocol development. It defines what qualifies as a research question and study hypothesis, lists the components of rigorous clinical research, notes some common weaknesses of different protocol designs, details the central elements of a study protocol, explores how to interpret protocols, and delineates the CRA’s role in monitoring a study site’s implementation of a protocol.

Recommended Use: Required ID (Language): 21178 (English) Author(s): Jessica Rosenbluth, MS - Syneos Health

" role="button"> Ethical and Participant Safety Considerations

This module examines the relevant national and international principles of participant protection in clinical research. It explains the ethical issues involved when working with vulnerable populations and describes the additional safeguards that should be in place to protect such subjects. The module also details the role of the study monitor in ensuring protection of participant rights in an ongoing clinical study.

Recommended Use: Required ID (Language): 21179 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Investigational Products Development and Regulation

This module explores the conception, development, testing, and approval of biomedical products and details the key stages of a biomedical product’s lifecycle. It defines the regulatory pathways for drugs, biologics, and medical devices, while describing how sponsors work with the U.S. Food and Drug Administration to gain approval for product marketing. The module provides CRAs with a working knowledge of the biomedical product lifecycle necessary to facilitate interactions between clinical research sponsors and sites.

Recommended Use: Required ID (Language): 21180 (English) Author(s): Robert Michalik, JD, RAC - RegulatoryPro Consulting

" role="button"> Clinical Study Operations (Good Clinical Practice)

This module provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) guideline, with a particular focus on sections that are most relevant to the work of a CRA. The module describes how a CRA’s monitoring activities help a site comply Good Clinical Practice (GCP). The module concludes with introduction to the proposed changes found in the E6(R3) update of the ICH guideline.

Recommended Use: Required ID (Language): 21181 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Understanding the Clinical Monitoring Plan

This module covers the roles and responsibilities of study monitors and details a monitoring plan's creation, purpose, and contents. It outlines risk-based and remote monitoring approaches and contrasts these with an earlier traditional model for monitoring. The module also focuses on the essential components of a monitor’s communication with investigators, study staff, and sponsors.

Recommended Use: Required ID (Language): 21182 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Implementing the Monitoring Plan

This module describes the preparation for and conduct of different site visits. It identifies the central actors involved and the common interactions among them. The module also details the key components of a visit follow up.

Recommended Use: Required ID (Language): 21183 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Emerging Clinical Trial Methods and Technologies

This module defines the purpose and use of emerging technologies for study management and data collection. It describes how these technologies enhance risk-based monitoring (RBM). In addition, the module discusses how decentralized clinical trial (DCT) modules are shaping the future of clinical trial conduct.

Recommended Use: Required ID (Language): 21184 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Data Management and Informatics

This module defines the core aspects of data management, describes quality clinical trial data, defines data-related milestones, and connects data processes to related systems and software. The module also outlines selected data-handling processes and provides CRAs with information on operational activities to maintain data quality at their assigned clinical trial sites.

Recommended Use: Required ID (Language): 21185 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Leadership, Communication, Professionalism, and Teamwork

This module describes some principles and practices of leadership, communication, professionalism, and teamwork related to clinical research. It describes how a CRA can leverage soft skills to effectively manage stakeholder relationships in a clinical trial.

Recommended Use: Required ID (Language): 21186 (English) Author(s): Clareece West, BSc - West-Fenn Enterprise, LLC

" role="button"> Who should take the Clinical Research Associate course?

Learners who wish to gain foundational knowledge of clinical research site monitoring should take this course to prepare for a career as a clinical research associate (CRA). The course is ideal for clinical research coordinators (CRCs) looking to transition to becoming CRAs and for organizations looking to onboard new CRAs.

Suggested audiences include new Clinical Research Associates, Clinical Research Coordinators, Contract Research Organizations, Faculty, Principal Investigators, Research Administrators, Sponsors, and Students.

" role="button"> Why should someone take the Clinical Research Associate course?

This role-based course provides the practical know-how to monitor clinical research sites effectively. It provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, clinical research coordinators (CRCs), and principal investigators.

" role="button"> How does the Clinical Research Associate course complement other CITI Program Courses?

Clinical Research Associate is a helpful complement to CITI Program’s Clinical Research Coordinator (CRC) Foundations and Clinical Research Coordinator (CRC) Advanced courses. It provides the next set of tools required for research monitors. CRCs looking to become CRAs will find that Clinical Research Associate is essential to making this professional transition.

" role="button"> What are the required and supplemental modules?

The modules for the Clinical Research Associate course are:

• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (Good Clinical Practice)
• Understanding the Clinical Monitoring Plan
• Implementing the Monitoring Plan
• Emerging Clinical Trial Methods and Technologies
• Data Management and Informatics, and
• Leadership, Communication, Professionalism, and Teamwork

The course is designed to be completed sequentially through all nine modules (we recommend they are set as “required”).

" role="button"> Is this course eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.

" role="button"> How long will the course take a learner to complete?

This course consists of nine modules. Each module contains detailed content, a quiz, images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around 4.5 to 5.5 hours to complete.

Related Content

CRC courses focus on key topics essential to the conduct of clinical research. They are specifically tailored to the needs of clinical research coordinators.

Discusses the importance of CRA soft skills in building productive relationships with sites and sponsors.

Discusses the process and content of a CRA’s interim monitoring visit.

Details ways to produce productive partnerships between clinical research associates and clinical research coordinators.

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How to become a clinical research associate (CRA)

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

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• Program Overview

The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning, and advancing global health. 

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP ®  " designation.

Path to Certification

CCRP certification is awarded upon meeting two criteria: a successful written application and a passing CCRP examination score. The benefits of obtaining certification are numerous. It not only validates knowledge, skills, and abilities but also enhances credibility and peer recognition. Career advancement and increased earning potential become tangible outcomes, reflecting a commitment to standards, compliance, and integrity.

Scope and Standards of Practice 

The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials.  It is the goal of SOCRA to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable federal, state and local laws and policies.  

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• 42 CFR Part 11 (ClinicalTrials.gov) 

Certification Exam

The SOCRA Certification Examination is offered in two formats: paper and pencil (at SOCRA sponsored sites), and computer based (at Prometric testing centers or through Home Proctoring).

SOCRA Sponsored Sites: Paper and Pencil

• Hosted exams offered in various location throughout the US and Canada.
• Visit the paper and pencil exam schedule for dates and locations.
• A complete application must be received by the deadline date as stated on the examination schedule.
• Score reports mailed to you in 4-6 weeks after exam.

Computer Based Testing: Testing Centers and Remote Proctoring 

• Offered at Prometric testing centers throughout the world or through Home Proctoring 
• Click here  for a list of test centers.
• Allow 2-4 weeks for application processing. 
• Once application is approved, schedule exam at a testing center.  Exam sessions are available at least 6 weeks in advance.  
• Score reports received immediately upon completion of exam. 

Candidate Handbook

For more information, please view the  Candidate Handbook.

Certification

• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

Summary of Certification Activities

11,145 CCRPs (as of 12/31/2022)

• 1,391 candidates took CCRP exam
• 73% passed CCRP exam
• 2,649 CCRPs recertified
• 946 candidates took CCRP exam
• 65% passed CCRP exam
• 2,783 CCRPs recertified
• 2,060 candidates took CCRP exam
• 70% passed CCRP exam
• 3,801 CCRPs recertified
• 1,980 candidates took CCRP exam
• 71% passed CCRP exam
• 3,188 CCRPs recertified
• 104 exam sites hosted
• 2,175 candidates took CCRP exam
• 2,491 CCRPs recertified
• 91 exam sites hosted
• 2,141 candidates took CCRP exam
• 2,421CCRPs recertified

33RD ANNUAL CONFERENCE

ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

FORGING STRATEGIC COLLABORATIONS

September 27 to 29

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Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

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Clinical Research Certificate Program

• Continuing Education

Home › Continuing Education Courses › Clinical Research Certificate Program

Clinical Research Certificate Program: at a glance

Credential(s) Earned: Certificate

Program Length: Varies depending on the student; on average 12-24 months

Start Date: Offered through Continuing Education

Tuition: Per-Course Basis

Description

The Clinical Research Certificate program is an online program that responds to the needs of the rapidly expanding field of Clinical Research, creating exciting opportunities for trained professionals.

Please note, NEW program requirements as of September 1, 2022 . All applications to the program after September 1, 2022 must meet the new requirements: 6 required each 4.8 CEUs with a total of 240 hours.

Required courses

CRCR130 (Principles of Clinical Research I) ETCR120 (Ethical Issues in Clinical Research) QCCR110 (Quality & Compliance in Clinical Research) MCCR140 (Monitoring Clinical Trials) RMCR110 (Research Methodology & Biostatistics) SCCR240 (Elements of Clinical Study Coordination)

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What are Clinical Trials?

Clinical trials are well controlled, scientific studies conducted on human subjects. These studies test the effects, risks and benefits of medicinal products, including new and currently marketed drugs and devices.

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Empowering healthcare change: program overview.

Embark on the Path to Clinical Research Excellence

What does a Clinical Research Professional do?

The Clinical Research Team is made of a number of professionals, each with its own role and responsibility to contribute to the overall success of the clinical trial. Members of the team include the investigator, research coordinator, sponsor, clinical research associate (monitor), quality assurance associate, nurses, technicians and more. These team members assist in the design, preparation, planning, implementation, conduct and review of a clinical trial to ensure it adheres to regulatory and ethical standards.

Why become a Clinical Research Professional?

Clinical Research professionals contribute to research studies that in turn have a major impact on health care, such as developing new medications, and testing new treatment devices and methods. Significant advancements in these areas and expanding regulatory requirements have increased the demand for trained clinical research professionals.

Career Opportunities

Clinical research is a rapidly expanding field, creating exciting opportunities for trained professionals. Clinical research professionals work in a broad range of research settings, including:

• Academic health centres
• Government agencies and departments
• Contract research organizations
• Physician practices
• Private companies, such as pharmaceutical, biotechnology, and medical device firms

Graduates of this program would seek entry level employment in the hospital or the private health sector. These employment settings may provide the opportunity to advance to more senior roles with additional education and/or experience.

Graduates of this program who meet the minimum requirements may be eligible to write certification examinations through either ACRP or SoCRA .

How long does the program take?

Michener’s Clinical Research Certificate program is offered online. Study on your own time, and complete the program in approx. twenty-four months depending on your schedule. Upon successful completion receive The Michener Institute’s Clinical Research Certificate of Achievement. 

Maximum time to complete the program would be one course per year; that is 6 required  courses, 6 years maximum to complete the certificate. 

Note: If you are currently working in Clinical Research you may be eligible for a Prior Learning Assessment, for the course Principles of Clinical Research I- CRCR130. Please contact [email protected] for more information. 

Courses for the Clinical Research Program are completed through continuing education on a course by course basis. Online courses are offered several times throughout the year. Many students wish to take these courses for interest only. You may register for these courses without applying for the certificate.

If you would like to be granted a certificate in this program, qualified students must meet the admission requirements as posted, including any language requirements, and must apply to the program with full supporting documentation before completing all required courses. This application can be made at any time while you are taking courses, however please note that it will take one month for the Registrar’s Office to process the application. If you are seeking admission to the certificate program prior to registering for a course, please ensure you apply for the certificate one month before Registration closes for the course. Please keep in mind that some courses close before the registration date if their maximum capacity is met.

If you plan to request the certificate, you must have approved acceptance into the program before completing the required courses.

NOTE: Anyone currently taking courses within Clinical Research Certificate program and have applied or will apply with acceptance received before September 1, 2022 are still eligible for the CR Certificate requirements, 4 required courses plus 1 elective. All applications after September 1, 2022 must complete new requirements, 6 required courses. 

Admission Requirements

Admission requirements to the Certificate Program are:

• Bachelor of Science in a health sciences field or
• Registered Nurse or
• Registration in one of the regulated health professions or
• Certification with a recognized body in one of the health technologies [e.g. certification with CSMLS, CSRT or CAMRT] or
• Current employment in clinical research
• Computer literacy

Please Note: Applicants who do not meet the above requirements but who have current, relevant work experience in an appropriate research environment will be assessed on an individual basis. Submission of two letters of support will be required; one from a direct supervisor and one from your human resources department. A current resume describing your background and experience will also be required.

Students must have access to a computer that meets the minimum system requirements , access to the Internet and an e-mail account.

Students must meet Michener’s English Language Requirements. Please visit Internationally educated applicants page for further information. If you require an English language assessment, please review our English Language Assessment page for specific requirements.

If you are in international applicant, please visit International Admission Procedures & Requirements

How do I apply?

To apply please submit the following documents to The Michener Institute:

• Completed Michener Application Form . You must submit application to the program before completing all required courses.
• Official academic transcripts and official copies of certification documents. Official notarized copies will also be accepted.
• All applicants for whom English is a second language must provide proof of an English language assessment.   If you are in international applicant, please visit International Admission Procedures & Requirements .
• A $50.00 non-refundable application fee

Your application should be sent to:

Office of the Registrar – The Michener Institute 222 St. Patrick Street Toronto, ON M5T 1V4 Canada Email: [email protected]

What will I learn?

When you enroll in Michener’s Clinical Research Certificate program, you will acquire the technical expertise, knowledge and interpersonal skills needed to become a valuable member of a clinical research team.

• Ethical theory and ethical issues related to clinical research
• Phases and elements of clinical trials
• Good clinical practices
• Health Canada, ICH and Food and Drug Administration regulations and guidelines
• Challenges in the conduct of clinical trials
• Monitoring clinical trials
• Quality and Compliance practices, guidelines and regulations in clinical research

Required Courses

• CRCR 130 Principles of Clinical Research I
• ETCR 120 Ethical Issues in Clinical Research
• SCCR240 Elements of Clinical Study Coordination
• QCCR110 Quality and Compliance in Clinical Research
• MCCR140 Monitoring Clinical Trials
• RMCR110 Research Methodology and Biostatistics

Note: If you are currently working in Clinical Research you may be eligible for a Prior Learning Assessment, for the course Principles of Clinical Research I- CRCR130. Please contact [email protected] for more information.

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Working together, we can reimagine medicine to improve and extend people’s lives.

Associate Director, Non-Clinical Statistics

About the role.

Major accountabilities:

·         Collaboration: Work closely with scientists, project teams, and disease areas to integrate statistical methodologies into research and development processes.

·         Statistical Support: Provide expert statistical support for non-clinical studies, ensuring robust data analysis and interpretation.

·         Innovation: Contribute to the development and application of innovative statistical techniques

·         Training and Mentorship: Mentor junior statisticians and data scientists, promoting a culture of continuous learning and professional growth..

·         Cross-Functional Representation: Represent non-clinical statistics on cross-functional teams to provide effective statistical consideration and collaborate closely with scientists across Biomedical Research.

·         Statistical Approaches: Ensure and implement statistically sound approaches for the design, analysis, reporting, and interpretation of exploratory and regulatory non-clinical studies.

Automation Development: Develop automated solutions

Education: Ph.D. or Masters in Statistics, Biostatistics, or a related field strongly preferred. 

• Experience: Minimum of 6 years of experience in non-clinical statistics, with a strong working knowledge in biology, pharmacology and toxicology .  
• Technical Skills : Expertise in statistical software and programming languages (e.g., R, SAS, Python).  
• Communication: Excellent communication and interpersonal skills, with the ability to engage effectively with diverse stakeholders.  
• Innovation: Demonstrated ability to drive methodological innovation and apply advanced statistical techniques to complex problems.  
• Fluent in English (oral and written) .    

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.