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
Recent 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 professional 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 and decision making, using broadly defined policies, practices and procedures, to resolve a variety of complex problems
Ability to work in a Team setting
Demonstrates excellent competency in written and verbal communication
High level of proficiency in Microsoft Word, PowerPoint and Excel, required
In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.
Competitive offer packages
Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/ )
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.)
Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.
UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known. We thank all applicants for their interest, however, only those selected for further consideration will be contacted.

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