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Overview

The Clinical Research program is designed to give students the knowledge and skills to prepare students for a variety of careers in clinical research. Graduates of the program will have the abilities to manage clinical trials under the supervision of a principal investigator and/or be involved in clinical research administrative activities in a variety of venues such as research sites in medical centres and hospitals as well as within the pharmaceutical and biotech industry, contract research organizations (CROs) and government.

Benefit From

  • Acquire foundational skills and techniques to be able to collaborate successfully with colleagues in the effective conduct of high quality clinical research,
  • Learn skills to facilitate critical appraisal of multidisciplinary research literature
  • Learn how to conduct and manage clinical research
  • Develop skills in communication, problem solving, educational methods, research and management, related to a clinical research
  • Industry-Developed Curriculum
 

Information Session

New students are invited to attend an information session.

Career Opportunities

Graduates of this program find employment in positions such as Clinical Research Assistant/Coordinator, Data Management professional, Clinical Trial Assistant/Associate, Quality Control Reviewer and Medical Writer. They may work for Contract Research Organizations(CROs), or as employees of physicians, hospitals or pharmaceutical companies.

The main functions performed by graduates are in entry level positions to:

  • provide administrative support to clinical trials
  • participate in the preparation of clinical trial protocols, informed consent forms and various clinical trial documentation
  • participate in the conduct of clinical trials while ensuring compliance with the clinical trial protocols and relevant regulations
  • manage data about trial participants and the investigational product using forms or databases provided
  • prepare reports and summaries of data obtained

Graduate Opportunities

For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.

National Occupational Classification (NOC) - Government of Canada

The National Occupational Classification (NOC) provides a standardized language for describing the work performed by Canadians in the labor market. It gives statisticians, labor market analysts, career counselors, employers and individual job seekers a consistent way to collect data and describe and understand the nature of work.

Entry Requirements

  • Applicants must have an accredited baccalaureate degree in Life Sciences, Nursing or a closely related field.
  • Applicants are selected on the basis of their academic credentials, English proficiency and Applicant Profile. English proficiency must be at the university level. Students who have completed University English courses must still write and successfully pass the English Assessment Test.

Mandatory English Assessment Test

English Assessment Test and Applicant Profile

Students applying to take the CRP program through the Faculty of Continuing Education and Training must complete the mandatory English Assessment Test and Applicant Profile. Please register for EPT002 online or call Registration at 416-493-4144, ext. 2. Please allow three hours for your test and CRP Application profile. The Profile takes about one hour and is completed after the assessment test.

The English Assessment Test and Applicant Profile is offered once each term, and must be written and assessed as part of the selection process. Both context and communication skills are assessed, and these in combination with prior academic achievement will form the basis for selection. Students will be notified in 2 or 3 weeks regarding their acceptance into the program through their personal email provided at the time of the test. Students who are successful will have to register in a Module I course. Module II courses can only be done if the appropriate prerequisite has been completed.

Note:

  • Students who miss the Mandatory English Proficiency Test will have to wait until the following term to enroll.
  • Students must bring a copy of their degree, photo ID and a current email address on the night of the English Proficiency Test as well as a pencil, eraser, and pen.

IMPORTANT:

If you are registered to write the EPT002 - English Proficiency Test, you are required to have your foreign degree evaluated either by WES (World Education Services) 416-972-0070, or the Comparative Education Services at the University of Toronto 416-978-2400 ext. 3 and must present the evaluation to the staff on the night of the EPT 002 test.

Applicant Selection

All eligible students must complete an Applicant Profile that will be assessed for content, writing skills, writing effectiveness and style. Students are selected into the CRP program on the basis of their academic credentials, successfully passing an English Assessment Test and the assessment of the written Applicant Profile.


Filter Classes: In Class     Online     Correspondence     Hybrid     Availability   


Curriculum

CRP100
Clinic Trial Regulations
Availability
 

This course provides an overview of the regulatory framework for the conduct of clinical trials. Topics include the role of regulatory agencies in the approval of new drugs/devices, relevant clinical trial regulations, the clinical trial application process and an evaluation of global healthcare systems as a factor in the conduct of clinical trials.




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CRP101
Introduction to Drug Development/Clinical Trials
Availability
 

This course introduces students to the process of drug discovery and development. Students are provided an overview of the relevance of preclinical trials, their purpose, roles, and the transition from pre-clinical to clinical trials. The essential studies necessary to initiate a clinical trial are introduced.




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CRP104
Clinical Study Administration
Availability
 

This course provides an overview of the management and conduct of clinical trials and the staff involved in conducting clinical trial research. Topics include essential documents in the clinical trial, the need for SOPs and qualified staff, and process for adequate oversight of the clinical trial.




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CRP108
Clinical Trial Design and Pharmacology
Availability
 

A clinical trial is a carefully planned and scientifically sound experiment. This course provides students with an opportunity to learn and understand the rationale of designing, conducting and successfully completing a clinical trial. Students gain understanding of drug action, metabolism and clearance.




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CRP113
GCP - Good Clinical Practice and Ethics
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TWC713
Technical Writing and Communication I
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CRP109
Clinical Research Data Management
Availability
 

Prerequisite(s):

CRP100, CRP101, CRP104, CRP108, CRP113, TWC713

Clinical research involves the collection of complete and quality data. Students learn the elements of Good Laboratory practice, sample collection, storage and transport. This course includes the use of Clinical Data Management Systems (REDCap, Medidata) to review the establishment and validity of clinical research data. Students will apply statistical analysis to clinical sample datasets.




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CRP106
Monitoring Clinical Research
Availability
 

Prerequisite(s):

CRP101, CRP113

This course outlines the various milestones of clinical research in relation to monitoring of the clinical site. The course defines the sponsor's and investigator's perspective and expectations in clinical research. Students gain the knowledge to ensure the study site processes and procedures are compliant and that data collected meets quality standards. Students learn the overall management and organization elements required to monitor a study effectively.




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CRP110
Medical Writing and Clinical Research Project
Availability
 

Prerequisite(s):

CRP100, CRP101, CRP104, CRP108, CRP113, PQA711, TWC713

Corequisite(s):

CRP106

In this course students develop a clinical trial protocol including a plan for training, monitoring and data management. Concepts including grant writing, literature reviews, communication skills and data interpretation will be covered. Students develop clinical trial documents including informed consent documents and case report forms for each study visit. Teams of students prepare presentations for lay and scientific audiences.




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CRP112
Clinical Auditing and Critical Analysis
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PQA711
Introduction to Quality Assurance
Availability
 

Corequisite(s):

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

This course focuses on the concept of Quality Assurance/Quality Control, planning and contribution of the Quality Assurance team in an organization. Topics covered include QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; auditing theory; process deviations and SPC/SQC; complaint-handling and product recall theory; and detailed training on GLPs, GMPs and the ISO Quality Standards.
Students gain significant "hands on" experience in document reviewing and SOP writing/reviewing as well as case study work in process deviation and audit investigations. These skills were intentionally built into the program to provide students with meaningful QA skills that can be applied to their employment activities without a large training investment on behalf of the company who accepts them.




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Program Outcomes

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

As a graduate, you are 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, and 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, and 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.

OSAP

OSAP Funding Available

This program is eligible for OSAP funding.

Course load is used by OSAP to determine funding options for programs.

If you are taking 1 - 2 courses at the same time, you may be considered for part-time student grants and loans.

  • 1 course (20%)
  • 2 courses (40%)

If you are taking 3 or more courses at the same time, you may be considered for full-time student grants and loans.

  • 3 courses (60%)
  • 4 courses (80%)
  • 5 courses (100%)

To find out if you qualify and to learn how to apply, please visit the OSAP website.

For information on other awards and financial assistance, please see Financial Aid.

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 Contacts




Georgina Ioannou
Program Assistant
Georgina.Ioannou@senecacollege.ca
416-491-5050 ext.22946


Gregory Staios
Part-time Program Coordinator
Gregory.Staios@senecacollege.ca
416-491-5050 ext.26450


Joanne Bonnet
Academic Program Manager
Joanne.Bonnet@senecacollege.ca
416-491-5050 ext.22528


Information Session

New students are invited to attend an information session.