Clinical Study and Regulatory Specialist I

University Health Network; Toronto; On-site; CAD 70,000 - 88,000; Full time

Benefits offered by this job

HOOPP pension plan

Transit access

Flexible work environment

Opportunities for development

Corporate discounts

On-site gym

Job summary

University Health Network invites applications for the Clinical Study and Regulatory Specialist I. The role leads study and regulatory coordination from activation to close-out of clinical trials.

You will prepare submissions, manage documentation, and support TMF/ISF maintenance in a fast-paced research environment. With a Bachelor’s degree in a health or science field and 2+ years in clinical research, you will ensure regulatory compliance and high-quality data management while collaborating

Qualifications

• Bachelor's degree in a health or science-related discipline required.
• Clinical Research Graduate Certificate preferred or equivalent.
• SoCRA/ACRP certification an asset.
• Minimum two years clinical or professional experience.
• Experience with regulatory/ethics submissions required.
• Knowledge of ICH/GCP, Tri-Council Policy, Helsinki Declaration and FDA/Health Canada guidelines.
• Strong data collection, management and analysis experience.
• Excellent written and verbal communication skills and teamwork.

Responsibilities

• Prepare regulatory submissions to local REB and regulatory agencies for approvals and amendments.
• Coordinate site qualification visits, feasibility surveys, initiation visits and protocol reviews.
• Manage regulatory documents, ethics submissions, protocols and staff training.
• Maintain study trackers and tools; update Data Management Plan as needed.
• Create or amend source documentation templates per data management requirements.
• Review and verify clinical data for accurate case report forms; ensure patient eligibility.
• Oversee data collection, entry, verification and reporting; resolve data queries.
• Coordinate on-site/virtual monitoring visits and audits by sponsors and regulators.
• Ensure regulatory compliance and manage study financials for the unit.
• Train new team members and support TMF/ISF maintenance.

Skills

Regulatory submissions

Clinical research

Data management

Communication

Teamwork

Attention to detail

Education

Bachelor's degree in health or science

Clinical Research Graduate Certificate

SoCRA/ACRP certification (asset)

Tools

MS Word

PowerPoint

Excel

Job description

Clinical Study and Regulatory Specialist I

• Full-time
• Department: Research
• Compensation: CAD 70,473 - CAD 88,101 - hourly

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.

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 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 regulatorysubmissions 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

• 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

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.

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.