Clinical Study and Regulatory Specialist I

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 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 on-site 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.  Duties • Preparing regulatory submissions 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 guideline