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University Health Network

Clinical Study and Regulatory Assistant

620 University Avenue, Toronto, ON, Canada

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Nov 19, 2026
Working hours: 37.5 hours per week
Positions available: 1
Posting language: English
Posted: Nov 5, 2026

Original job description

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.

Department: Research

Compensation: CAD 54951 - CAD 68699 - yearly

Apply About employer

More about this job

Responsibilities

The Clinical Study and Regulatory Assistant facilitates the operational management of non-patient facing activities for clinical research studies. Responsibilities include data entry into electronic systems, maintaining regulatory compliance, and preparing submissions for the Research Ethics Board.

Requirements

Candidates must have at least a community college diploma in a health-related discipline and 3 to 6 months of related experience. A bachelor's degree and a Clinical Research Graduate certificate are preferred qualifications.

Skills

Clinical research
Regulatory compliance
Data collection
Data entry
Case report forms
Ethics submissions
ICH-GCP
FDA regulations
Electronic data capture
Redcap
Medidata
Communication skills
Organization
Prioritization
Attention to detail
Interpersonal skills

Benefits

Healthcare of Ontario Pension Plan
Flexible work environment
Corporate discounts
Travel discounts
Restaurant discounts
Parking discounts
Phone plan discounts
Auto insurance discounts
On-site gyms
Professional development opportunities

Visa sponsorship

Not detected in the job text

Keywords

Clinical Trials
Regulatory Affairs
Medical Oncology
Hematology
Research Ethics Board
ICH-GCP
FDA
Tri-Council Regulations
Electronic Data Capture
Redcap
Medidata
Data Integrity
Clinical Research Manager
Protocol Management
Source Documentation
Study Close-out
Archival
Healthcare
University Health Network
Patient Care

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