Clinical Study and Regulatory Assistant

Union:  Non Union Number of vacancies:  1 Replacement or New:  New Site:  Toronto General Hospital  Department:  Hepato-Pancreato-Biliary (HPB) Research Program Reports to:  Clinical Research Manager Hours: 37.5 hours/week Shifts:  Days Salary Wage:  $28.18 - $35.23 per hour Status: Temporary Full-time (1 year contract; possibility of extension)  Closing Date: November 19, 2026 Position Summary This research position is with the HPB Oncology Research Group at Princess Margaret Cancer Centre/Toronto General/UHN. Our portfolio includes epidemiological, translational and clinical research led by a multidisciplinary group of clinician scientists. Our focus on genomics, biomarkers and novel therapeutics make this an exciting position for research personnel with basic/translational and clinical knowledge and interests. This position offers an exciting research opportunity for an extremely organized, highly motivated, detail-oriented and hard-working individual, who possesses strong communication and interpersonal skills, and will enjoy the challenge of learning from and working with an interdisciplinary research team. Duties As a Clinical Study and Regulatory Assistant, under the supervision of the program managers and other team members, you will be responsible for: • Collect, enter, verify, and report clinical research data in accordance with study protocols and regulatory requirements. • Enter medical and research data from health records and other authorized sources into electronic data capture (EDC) systems (e.g., REDCap, Medidata) with a high degree of accuracy and data integrity. • Identify, document, and track protocol deviations and standard operating procedure (SOP) non-compliance. • Coordinate the ordering, preparation, and management of study blood collection kits and related supplies. • Support Clinical Research Coordinators and Clinical Research Nurses in ensuring participant compliance with study requirements by coordinating study procedures, including blood draws, imaging, questionnaires, and other protocol-mandated assessments within required timelines. • Facilitate the resolution of sponsor and internal data queries by reviewing discrepancies, issuing query requests, and coordinating follow-up with study team members and external stakeholders. • Execute study-related administrative and regulatory activities, including the collection, maintenance, and organization of essential documents, ethics approvals, protocols, staff training records, and delegation logs in both electronic and paper formats. • Create, maintain, and update study trackers and operational tools, including screening logs, enrolment trackers, eligibility checklists, and study management worksheets. • Act as a liaison between study sites, sponsors, and research team members to ensure timely communication and distribution of study-related documentation, updates, and regulatory requirements. • Ensure ongoing regulatory compliance for human subjects research by adhering to study protocols, institutional policies, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. • Coordinate study close-out activities, including reconciliation, archiving, and retention of essential study documents in accordance with institutional and regulatory standards. • Community college diploma in a health-related discipline, or equivalent, required • Bachelors degree in a health or science-related field or equivalent, preferred  • Clinical Research Graduate Certificate, preferred  • 3 to 6 months related experience, Clinical Research experience 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 • Ability to perf