Clinical Study and Regulatory Specialist I (Toronto)

Clinical Study and Regulatory Specialist I (Toronto)

19 Apr
|
University Health Network
|
Toronto

19 Apr

University Health Network

Toronto

Clinical Study and Regulatory Specialist I

- Contract
- Department: Research
- Compensation: CAD 68,932 - CAD 103,409 yearly

UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital. With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre. As Canada’s top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. UHN has the largest hospital‑based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. UHN is a research hospital affiliated with the University of Toronto.

UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

Union: Non-Union

Number of Vacancies: 2

New or Replacement Position: New

Site: Princess Margaret Cancer Centre

Department: BRAS Drug Development Program - Phase II

Reports to: Clinical Research Manager

Salary Range: $68,932- $103,409 Annually

Hours: 37.5 Hours Per Week

Shifts: Day Shift

Status: Permanent Full-time

Closing Date: April 30, 2026

Position Summary

The Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only center outside of the United States to have a contract with the National Institutes of Health (NIH).



The Drug Development Program includes a Phase II program, focusing on studies across all the various phases of trials with a strong emphasis on pharmacokinetics, translational studies and Investigator Initiated Trials. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.

Responsibilities

- Coordinates studies from activation to close‑out
- Ensure the collection and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice
- Collect and abstract data from source documents
- Monitoring of data and preparing submissions to Health Canada and Research Ethics
- Ensure all data is complete, accurate, timely and must be in compliance with applicable ICH GCP, FDA and US federal code and Tri‑Council regulations
- Interpret applicable regulations to ensure compliance
- Responsible for study‑related administrative tasks
- Collaborate with cooperative groups, pharmaceutical companies, or internal PMH studies

Qualifications

- At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
- At least 1-2 years experience in Oncology, Clinical trials, medical terminology,



regulatory issues involving human subjects
- Some experience with Health Canada regulatory submissions and site management
- Demonstrated relevant clinical research knowledge
- Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
- Excellent interpersonal skills, satisfactory attendance
- Ability to work under pressure and attention to detail
- Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with UHN standards
- Ability to perform multiple concurrent tasks
- Knowledge of applicable legislative, UHN and/or departmental policies
- Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand
- Certification as a Clinical Research Professional, preferred

Benefits

- Competitive offer packages
- Government organization membership of the Healthcare of Ontario Pension Plan (HOOPP)
- Close access to Transit and UHN shuttle service
- A flexible work environment
- Opportunities for development and promotions within a large organization
- Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on‑site gyms, etc.)

UHN is an equal chance employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process.

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📌 Clinical Study and Regulatory Specialist I (Toronto)
🏢 University Health Network
📍 Toronto

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