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Added 9 mins ago
MC
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University Health Network

Clinical Study and Regulatory Specialist I

190 Elizabeth Street, Toronto, ON, M5G 2C4, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 11, 2026
Education: Bachelor’s degree
Working hours: 37.5 hours per week
Positions available: 1
Posting language: English
Posted: Oct 28, 2026

Original job description

Company Description

UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital. With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre. As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. UHN is a research hospital affiliated with the University of Toronto.

UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

www.uhn.ca

Job Description

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.

Department: Research

Compensation: CAD 70473 - CAD 88101 - hourly

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More about this job

Responsibilities

The specialist will lead study and regulatory coordination from activation to close-out of clinical research trials. Responsibilities include preparing regulatory submissions, managing monitoring visits, and ensuring data integrity and compliance with research protocols.

Requirements

Candidates must hold a bachelor's degree in a health or science-related discipline and have at least two years of professional experience, including one to two years in clinical research. Proficiency in regulatory submissions and data management software is required.

Skills

Regulatory submissions
Clinical research
Data management
Protocol compliance
Medical terminology
Ethics submissions
Source documentation
Study coordination
Financial management
ICH/GCP guidelines
Microsoft Word
Microsoft PowerPoint
Microsoft Excel
Audit preparation
Regulatory compliance

Benefits

Healthcare of Ontario Pension Plan
Competitive offer packages
Transit access
Shuttle service
Corporate discounts
On-site gyms

Visa sponsorship

Not detected in the job text

Keywords

Clinical Trials
Regulatory Affairs
REB
FDA
Health Canada
TMF
ISF
SoCRA
ACRP
ICH/GCP
Tri-Council Policy
Declaration of Helsinki
Data Management Plan
Case Report Forms
Protocol Deviations
Source Data Verification
Study Financials
Biomedical Research
Cardiology
Oncology
Clinical Research Specialist
Regulatory Compliance
Audit
Data Entry
Medical Records

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