Clinical Research (CRQ)

Note: This program is not accepting applications for May 2026

About the Program

This one-year certificate program, you will learn research design concepts, analysis and the quality assurance required for daily operations in the clinical research field. You will examine clinical studies across the pharmaceutical, medical device and natural health product sectors that give the competitive edge required in this dynamic industry. In this hands-on program, you will work alongside industry professionals and develop a network of contacts ahead of graduation.

Part-time option is available >

Credential Awarded

Ontario College Graduate Certificate

Duration

2 Semesters (1 Year)

Starts

January, May, September

Program and Course Delivery

This program is offered online. Students learn remotely and do not need to come to campus. Online learning can be synchronous – scheduled class time with professors – or asynchronous – no scheduled class time, with all learning independent.

Skills

Throughout this program you will develop the following skills:

Conduct research design concepts
Analysis and quality assurance of daily operations in clinical trials development process for products such as drugs, medical devices, biopharmaceuticals and natural health products
Identify the roles and responsibilities of the different positions within the clinical research processes
Learn to incorporate ethical practices

Work Experience

Optional Work Term

This program offers the option to complete a work term, providing valuable hands-on experience in your field of study.

Students who select the work term stream will have the opportunity to participate in a work term(s) if eligibility requirements are maintained. Students will have the flexibility to transfer to the non-work term stream at any time. The work term(s) is similar in length to an academic semester and is typically a full-time position that may be paid or unpaid. The work term job search is student-driven and participation in the work term stream does not guarantee that a work position will be secured. However, students will receive guidance and support through in-class career workshops and one-on-one coaching to help prepare for the work term.

Review eligibility requirements for work-integrated learning

Students interested in completing a work term should apply to the Clinical Research (Work Term) (CRQC) program.

Your Career

Graduates of the program can explore the following career options:

Clinical research assistant
Clinical research associate
Clinical records associate
Clinical trials monitor

Affiliations and Associations

Clinical Research Association of Canada (CRAC)
Network of Networks (N2)
Consortium of Academic Programs in Clinical Research (CoAPCR))

Program of Study

Course List
Course Code	Course Name	Weekly Hours
Semester 1
CRP100	Clinical Trial Regulations	3
CRP101	Introduction to Drug Development/Clinical Trials	3
CRP104	Clinical Study Administration	3
CRP108	Clinical Trial Design and Pharmacology	3
CRP113	GCP - Good Clinical Practice and Ethics	3
PQA712	Introduction to Clinical Quality Assurance	3
TWC714	Technical Writing and Communication I - Clinical Research	3
WTP100	Work Term Preparation ^*	1
Work-Integrated Learning Term
CRQ441	Clinical Research, Work Term ^*	30
Semester 2
CRP106	Monitoring Clinical Research	3
CRP109	Clinical Research Data Management	3
CRP110	Medical Writing and Clinical Research Project	3
CRP112	Clinical Auditing and Critical Analysis	3

*: Work-Integrated Learning option - CRQC only

Program Learning Outcomes

This Seneca program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Colleges and Universities.

As a graduate, you will be prepared to reliably demonstrate the ability to:

Apply Health Canada and FDA regulations to clinical research.
Explain the product development process for products such as drugs, medical devices, biopharmaceuticals and natural health products.
Identify the roles and responsibilities of the different positions (Principle Investigator, Clinical Research Associate, Clinical Research Monitor, Study Participant) within the clinical research process.
Communicate professionally both orally and in writing within the clinical research environment.
Create documentation examples that are integral to clinical research.
Interpret data collected in clinical lab procedures.
Describe Good Clinical Practices as they apply to different aspects of the Clinical Trial.
Analyze the principles of quality assurance as they apply all aspects of clinical research.
Assess the compliance of clinical trial aspects to regulatory requirements (GCP, CLP, GMP).
Incorporate ethical practices in all stages of the clinical trial.
Compare and summarize international regulations, clinical requirements and best practices for the clinical research process.
Design a clinical study for a given drug, medical device, biopharmaceutical and/or natural health product that complies with industry and government standards and protocols.

Admission Requirements

Ontario university/college degree, college diploma or equivalent in life sciences, nursing or a related field of study. Postsecondary studies must include physical sciences courses such as chemistry and biology.
English proficiency for graduate certificates.

Canadian citizens or permanent residents educated outside of Canada must provide a World Education Services (WES) or ICAS Canada credential evaluation.

International Student Information

International admissions requirements vary by program and in addition to English requirements, programs may require credits in mathematics, biology, and chemistry at a level equivalent to Ontario’s curriculum, or a postsecondary degree or diploma, equivalent to an Ontario university or college. Program-specific pre-requisite courses and credentials are listed with the admission requirements on each program page. To review the academic requirements please visit: Academic Requirements - Seneca, Toronto, Canada (senecapolytechnic.ca).