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Clinical Study and Regulatory Specialist I

University Health Network

Toronto, ON

Job typeFull-time
SpecialtyClinical
Compensation$70,473 – $88,101/hour
Posted2 weeks ago

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Location190 Elizabeth Street M5G 2C4, Toronto, ON, CAOpen

eHealth role summary

Position involves management of clinical trial data, creation of Data Management Plans, use of data management/statistical software, maintenance of TMF/ISF, and regulatory submissions — i.e., clinical research informatics/health data management.

About this role

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

Qualifications

  • 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

Additional Information

Why join UHN?

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.

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates.  Please ensure you check your email regularly. 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. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

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.