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Certificate in Clinical Research

Certificate in Clinical Research

Drive the next generation of treatments and therapies

Next Enrolment

January 24th

Tuition

$6,594

Overview

COVID-19 Updates and changes to program delivery. More information >

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 is Clinical Research?

Clinical research is an area of healthcare science that focuses on the integrity of medical trials. A clinical research professional is involved in the organization and management of studies conducted across multiple phases to assess the safety and effectiveness of medications, vaccines, devices, diagnostic products and treatment plans.

The field of clinical research is highly regulated by federal, provincial and international legislation and standards. A clinical research professional is adept at interpreting and navigating the regulatory environment and applying these parameters to the successful execution of clinical trials.

What you will learn

In this part-time, six-course certificate, you will learn from instructors who are leaders in the clinical research field and bring years of expertise working in senior roles in major multinational pharmaceutical companies, biotech firms, clinical research organizations (CROs), hospitals and research institutes. Our instructors bring a practical perspective to the curriculum and will prepare you to:

  • 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

In this program, you will apply clinical trial procedures, regulations and best practices through experiential assignments, projects and case studies. You will also advance through the program with the same cohort of peers, allowing you to develop a strong professional network that you can leverage throughout your career.

In our unique Capstone course, you will collaborate to combine all previous learnings in an applied clinical research management simulation. By taking your hands-on experience to the next level, you will be ready to begin your career with confidence and add immediate value to this dynamic industry.

Our accelerated blended study option combines live classes with asynchronous online learning, allowing you to complete much of your course work online on your own schedule, while benefitting from opportunities to interact with your instructors and classmates. Balance your commitments, while completing the program faster and earning your certificate in only nine months.

Format: Part-time, Blended
Delivery: Online coursework + required live online sessions
Term Starts: Winter
Program Length: 9 months

 

Introducing Live Online Learning

To make our programming even more accessible, and to ensure the safety of students and instructors, we are now offering the in-class course components for professional programs completely online.

This certificate is designed for learners with a health sciences or related background. Please review our program requirements here.

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 Trial Associate
  • Clinical Research Coordinator
  • Clinical Trials Coordinator
  • Clinical Trials Monitor
  • Clinical Data Coordinator
  • Clinical Regulatory Coordinator
  • Clinical Study Specialist
  • Study Start Up Associate
  • Site Activation Lead
  • Clinical Project Associate I
  • Clinical Project Manager I
  • Junior Project Manager

Gain these cross-functional skills:

  • Ethics & Integrity
  • Critical Thinking & Problem Solving
  • Patient Interaction & Interpersonal Skills
  • Teamwork & Collaboration
  • Time Management & Prioritization
  • Relationship & Stakeholder Management
  • Clear Communication (written & verbal)
  • Agility & Adaptability to a Changing Environment

Clinical Research professionals can find employment across a variety of organizations, including:

  • Pharmaceutical Companies
  • Clinical Research Organizations (CROs)
  • Hospitals
  • Research Institutes
  • Biotechnology Firms
  • Site Management Organizations (SMOs)
  • Medical Device Companies
  • Universities & Academic Institutions
  • Private Practice

Who should take this program?

Registration Requirements:
The Certificate in Clinical Research is designed for individuals with a health sciences background who are looking to specialize and apply their pre-existing knowledge and expertise to this exciting field.

Prospective students for this program include:

  • New Graduates and Early Career Professionals with a related degree who are looking to specialize their skills and experience in this growing industry
  • Internationally Educated Medical Doctors (IMDs) and Internationally Educated Health Practitioners (IEHPs) who wish to meaningfully apply their existing skills and experience
  • Trained Nurses (RNs, RPNs) seeking opportunities for professional growth and advancement
  • Laboratory and Medical Technicians & Technologists who are looking to move into a related career
  • Individuals presently working in clinical research but who lack the training to advance in the clinical research industry

Prerequisites:

Please carefully review the prerequisites below to determine if this is the right program for you. Individuals who wish to register for this program should have the following:

  • University Degree in Health Sciences or related. This may include, but is not limited to: life sciences, biology, medicine, nursing, nutrition, physiology, anatomy, pharmacy, pharmacology, kinesiology, biochemistry, epidemiology, or health informatics.

OR

  • College Diploma in Health Sciences or related who bring prior experience in the healthcare or clinical research sector.

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

 IELTS (Academic Only) 6.5 (with no score less than 6.5)
 TOEFL Paper  550
 TOEFL Computer  213
 TOEFL Internet  79-80
 TOEIC  736
 Cambridge ESOL  176 (CI Advanced)
 PTE Academic  58
 YUELI AP Level  9
GSPP (Graduate Studies Program) Pass
Duolingo 115


If you have any questions about your eligibility for this program, please contact continue@yorku.ca and we would be happy to assist you.

Delivery Format

Part-Time – Blended

In this certificate program, courses combine online learning with live, real-time instruction at York University campus or virtually via Zoom due to COVID-19. The majority of the program delivery is asynchronous online, which means that while students have set deadlines to complete their work each week, they have the flexibility to manage their schedule and various commitments.

The live components are held over 1-2 weekends per course (e.g. Saturday and Sunday, 9:00am – 4:00pm), where students and instructors participate in active learning activities, share their learnings in an interactive format and hear from guest speakers. There may be additional optional live sessions offered via Zoom throughout the courses, which allow instructors the opportunity to provide students with additional coaching and support. These optional sessions will be recorded and shared with students who are unable to attend.

In addition to the live components, students should expect to dedicate approximately 8-12 hours of effort each week for readings, discussions boards, practice opportunities, and assignments.

Courses

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.

4 Classes

27 Hours

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.

4 Classes

27 Hours

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.

4 Classes

27 Hours

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.

4 Classes

36 Hours

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.

4 Classes

27 Hours

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.

4 Classes

23 Hours

Instructors

Taymour Bibi, HBSc.

Global Studies Leader, Hoffmann-La Roche

Ronak Dhanak, B.D.S., ACRP-CP, ACRP-PM

Global Study Associate Manager, AstraZeneca Canada

Tracy Heeney, BSc., MRT(N)

Clinical Project Manager, Janssen Inc., the pharmaceutical division of Johnson & Johnson

Amin Jagani, HBSc., BPharm, RPh, MBA

Associate Director, Clinical Project Management, Parexel Biotech, Inc.

Miran Kenk, PhD, CCRP

Scientific Associate, University Health Network – Princess Margaret Cancer Centre

Celin Sabu, BSc., MSc.

Global Studies Manager, Hoffmann-La Roche

Advisory Council

Taymour Bibi, HBSc.

Global Studies Leader, Hoffmann-La Roche

Nicole Campbell, HBSc, CCRP

Associate Director, Clinical Trial Leader, EMD Serono

Robert V. Campos, PhD

Senior Director, Research Operations and Therapeutic Innovation, Ontario Institute for Cancer Research

Netal Desai, MD, MBBS, CCRP

Vice President Clinical Operations, Novum Pharmaceutical Research Services

Mariana Di Laudo, HBSc., MBiotech, PMP

Director, Americas, Clinical Operations & R&D, GSK

Lisa M. Goos, HBSc., BEd., PhD

Director, Clinical Research Services, The Hospital for Sick Children

Nadia Romano, HBSc.

Director, Global Program Management - ICON Functional Services, ICON plc

Julie Szirtes, HBSc., M.Sc.

Director, Clinical Research & Development, Apotex Inc.

Certificate in Clinical Research

Winter 2022

Blended
(Online + Live Online Classes)

Course Details +

$6,594.00

Policies & More Information

Technology Requirements for Remote/Online Courses

Please review the technology and software requirements you will need to access our courses remotely.

Contact us

Ask us anything about this program and we’ll get back to you within 2 business days.