Clinical Study and Regulatory Specialist I

- Full-time
- Department: Research
- Compensation: CAD 70,473 - CAD 88,101 - hourly

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:1
New or Replacement: New
Site:Toronto General Hospital
Department:Clinical Trials and Translation Unit (CTTU), Peter Munk Cardiac Centre
Reports to:Clinical Research Manager
Salary Range: $70,473 to $88,101 per annum
Hours:37.5 hours per week
Shifts:Days
Status:Permanent Full-Time
Closing Date: November 11, 2026
Position Summary





The'Clinical Study and Regulatory Specialist I' (CSRS I)will report to the Clinical Research Manager of the CTTU and will lead study and regulatory coordination from activation to close-out of clinical research studies/trials.
Duties

- Preparing regulatorysubmissions to local REB, regulatory agencies (FDA, Health Canada, etc.) for initial approval, amendments, reportable events/SAEs, annual renewals, study closures, etc.
- Managing site qualification visits, site feasibility surveys, site initiation visits and protocol reviews including presentations and source documentation collection and getting the site ready for study start-up
- Executing study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs
- Maintenance and modification of study-specific trackers and study tools
- Creating or amending source documentation templates in accordance with data management requirements
- Ability to put together a Data Management Plan
- Reviewing, evaluating and verifying clinical data to ensure accurate and timely completion of case report forms
- Verifying patient eligibility for study participation based on medical records in accordance with protocol requirements
- Data collection, entry, verification and reporting
- Resolution of data queries (internal or sponsor initiated)
- Identification and logging of protocol and SOP deviations




- Managing on-site/virtual monitoring visits and collecting necessary source documentation for source data verification
- Organizing and preparing for remote and onsite monitoring visits for audits by external sponsors, internal and/or external regulatory agencies
- Ensuring and maintaining regulatory compliance for clinical research studies
- Managing study financials for the unit for various trials
- Maintaining centralization of essential documents for the unit
- Contributing to the maintenance of TMF/ISF for various trials
- Coordinating study close-out activities as well as archival of study documents
- Assisting with and/or training new research team members

- Bachelor's degree in a health or science-related discipline (required)
- Clinical Research Graduate Certificate (preferred) Or recognized equivalent of education and experience
- SoCRA/ACRP certification, an asset

- At minimum, two (2) years clinical and/or qualified experience

- One to two (1-2) years of clinical research experience, preferred

- Previous experience with regulatory/ethics submissions, required
- Experience using statistical analysis and data management software applications, preferred
- Knowledge of research regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPD
- Knowledge of medical terminology, required
- Experience in data collection, management and analysis, required
- Knowledge and experience in managing TMF/ISF structures,an asset
- Demonstrable experience in handling study financials is highly preferred
- Ability to exercise independent judgement a

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