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
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.
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)
- Association of Clinical Research Professionals (ACRP)
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.
Pathways
As a leader in academic pathways, we offer a range of options that will allow you to take your credential further in another Seneca program or a program at a partner institution.
To learn more about your eligibility, visit the Academic Pathways web page.