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.
New or Replacement: New
Site: Toronto General Hospital
Department: Clinical Trials and Translation Unit (CTTU), Peter Munk Cardiac Centre
Reports to: Clinical Research Manager
Shifts: Days
Permanent Full-Time
Position Summary The Clinical Trials and Translation Unit (CTTU) within the Peter Munk Cardiac Centre (PMCC) at Toronto General Hospital (TGH, UHN) is a centralized and consolidated research unit that provides operational support to the world-renowned cardiologists, cardio-oncologists, electrophysiologists, cardiovascular surgeons, interventional cardiologists, and other investigators at the PMCC. TeamCTTU is growing and is looking forward to welcoming an enthusiastic data and regulatory professional to join our team and be part of the many innovative initiatives and clinical trials ongoing at local, national and international stage. Interested applicants must be willing to work in office full-time.
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.
Preparing regulatory submissions to local REB, regulatory agencies (FDA, Health Canada, 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
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)
Managing in office/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




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
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
Ability to exercise independent judgement and decision making, using broadly defined policies, practices and procedures, to resolve a variety of complex problems
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 perks, programs and perks. Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP )
A flexible work environment
Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)
At University Health Network (UHN), artificial intelligence technologies may be used to assist in the screening, assessment, and selection of candidates for this position.
Please be advised that a Criminal Record Check may be required of the successful candidate. Requests for accommodation can be made at any stage of the recruitment process.

📌 Clinical Study & Regulatory Specialist I (Permanent Full Time) (Toronto)
🏢 University Health Network
📍 Toronto