Clinical Research

  • Program Accreditation: Diploma
  • 20 weeks – Total hours: 685

Program Overview

The Clinical Research Diploma Program is designed for many students interested in working in observational studies and clinical trials. This hands-on program provides a good understanding of clinical research and increases employment and job advancement opportunities. Students will learn how to generate and validate hypotheses; research bibliographic databases; design clinical trial studies; write clinical trial protocols; collect clinical research data; apply statistical tests for analysis of collected clinical research data; and work with stakeholders including pharmaceutical, biotechnology, and medical device companies.

Career Opportunities

Successful graduates are fully prepared for diverse careers in clinical research. With a strong foundation in clinical research fundamentals and practical experience in the clinical research environment, students will be ready for any number of careers, including jobs in the pharmaceutical industry, contract research organizations, research institutions, regulatory authorities, and more..

Admission Requirements

  • An Ontario Secondary School Diploma or equivalent; or be at least 18 years of age or older and pass an entry test.
  • English proficiency requirement for international students.

Graduation Requirements

To successfully meet the program outcomes the student must:

  • Achieve a minimum mark of 65% in all of the module assignments and exams

What you Will Learn

The course consists of 21 modules. These modules are covered in the classroom.

  • Study Designs in Epidemiology
  •  Statistics in Clinical Research
  •  Ethics in Clinical Research
  •  Hypothesis Generation and Validation
  •  Guidelines: Good Clinical Practice, Good Laboratory Practice, Good Documentation Practice, Good Manufacturing
  • Overview: Preclinical Drug Development
  • Study Designs in Clinical Research and Protocol Writing
  • Clinical Operations: Introduction to Regulatory Affairs and Submission of Human Research Ethics Application
  • Clinical Operations: Introduction to Pharmacokinetics
  • Clinical Operations: Introduction to Pharmacodynamics
  • Clinical Operations: Introduction to Product Management
  • Clinical Operations: Introduction to Clinical Study Conduct
  • Clinical Operations: Introduction to Clinical Data Management
  • Clinical Operations: Introduction to Pharmacovigilance
  • Clinical Operations: Introduction to Quality Assurance and Quality Control 
  • Clinical Operations: Introduction to Clinical Trial Monitoring
  • Medical Monitoring
  • Clinical Operations: Introduction to Regulatory Submission of Study Reports
  • Medical Writing
  • Microsoft Word, Excel, Outlook, and PowerPoint
  • Resume Preparation, Interview Skills, and Work Ethics

JOB FINDING WORKSHOPS ARE INCLUDED

  
The Medical Office Administrator Program is approved as a vocational program under the Ontario Career Colleges Act, 2005.

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