Clinical Study and Regulatory Assistant

Company Description

The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground breaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, the University Health Network (UHN), Canada’s largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.

Job Description

Union: Non-Union
Number of vacancies: 1
New or Replacement Position: New
Site: Princess Margaret Cancer Centre
Department: Department of Medical Oncology and Hematology – Clinical Trials Group
Reports to: Clinical Research Manager
Salary Range: 54, 951 - $68, 699 per annum
Hours: 37.5 hours per week
Shifts: Monday - Friday
Status: Permanent Full-time
Closing Date: November 19, 2026

Position Summary

Working under the direction of the Clinical research Manager, the Clinical Study and Regulatory Assistant (CSRA), will facilitate the operational management of non-patient facing activities to support the conduct of clinical research studies and clinical trials. Principal responsibilities include monitoring and promoting the quality and integrity of data, recording clinical trial data in case report forms (CRFs), and compilation of ethics and regulatory documents. Data is assessed, compiled, recorded and submitted to pharmaceutical companies or used for internal studies. These activities are executed in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations, policies, guidelines, and standard operating procedures.

Duties

• Assists the inter-professional clinical research team in performing study-specific tasks as per protocol
• Responsible for data collection, entry, verification and reporting
• Enters medical data from health records or other sources, as per approved study protocol and authorized access into electronic data capture (EDC) systems for example Redcap, Medidata, etc.
• Prepares submissions (amendments, reportable events, annual renewals, study closures) to Research Ethics Board (REB)
• Scheduling on-site/virtual monitoring visits and collecting necessary source documentation for data verification
• Liaises between site and sponsor to ensure that all trial-related documentation and information are distributed to relevant staff involved with the trial
• Ensures and maintains regulatory compliance for clinical research studies involving human subjects by following appropriate protocols
• Coordinates the close-out phase of clinical study protocols as well as archival of study documents

Qualifications

• At minimum community college diploma in a health-related discipline, or equivalent, required
  • Bachelor's degree in a health/science discipline, or equivalent, preferred
  • Clinical Research Graduate certificate, preferred
• 3 to 6 months related experience required
• Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
• Excellent interpersonal skills
• Ability to work under pressure and attention to detail
• Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines in accordance to UHN standards
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative, UHN and/or departmental policies
• Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand

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.