About the Role
Role details below.
Responsibilities
- 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
Requirements
- Must be willing to work on-site full-time
Compensation
$68,932 to $103,409 per annum
Work Arrangement
On-site
Team
Structure: Reports to Clinical Research Manager within the CTTU at Toronto General Hospital. Reports to: Clinical Research Manager
Additional Information
- Union: Non-Union
- Number of vacancies: 1
- New or Replacement: New
- Site: Toronto General Hospital
- Department: Peter Munk Cardiac Centre
- Hours: 37.5 hours per week
- Shifts: Days
- Status: Permanent Full-Time
- Closing Date: May 8, 2026
