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 perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
• Strong verbal & written communication skills
• Exceptional organizational & time management skills & attention to detail
• Ability to multi-task & perform with accuracy in a fast-paced environment
• Well-developed leadership & excellent interpersonal skills
• Self-motivated; ability to work well independently as well as part of a team
• Strong analytical & problem solving skills
• Excellent decision-making, listening & conflict resolution skills

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.