Clinical Study and Regulatory Specialist I

University Health Network; Toronto; On-site; CAD 48,216 - 73,012; Full time

Benefits offered by this job

Competitive offer packages

HOOPP pension plan

Transit access

Flexible work environment

Development opportunities

Corporate discounts

Job summary

University Health Network (UHN) is seeking a Clinical Study and Regulatory Specialist for the Tumor Immunotherapy Program at Princess Margaret Cancer Centre. You will coordinate trials, prepare submissions to Health Canada and REB, and manage study documentation to ensure data quality and regulatory compliance.

The 19‑month temporary full‑time contract offers exposure to a leading cancer research program and opportunities to advance in clinical research within a large health system.

Qualifications

• Bachelor’s degree in Health or Science‑Related Discipline required.

Responsibilities

• Coordinate clinical trial activities from protocol review through to activation, follow up and closure.
• Prepare Health Canada and Research Ethics Board submissions.
• Maintain study trackers and regulatory documents; ensure data quality and compliance with ICH‑GCP, FDA and Tri‑Council regulations.
• Communicate effectively with stakeholders and support study staff in a fast‑paced environment.

Skills

Excellent communication

Organizational skills

Independent worker

Fast learner

Education

Bachelor’s degree in health or science-related discipline

Job 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

• Union: Non-Union
• Number of vacancies:1
• New or Replacement Position: Replacement
• Site: Princess Margaret Cancer Centre
• Department: Tumor Immunotherapy Program
• Reports to: Clinical Research Manager
• Salary Range: $35.35 – $53.03 per hour
• Hours: 37.5 hours per week
• Shift: Monday to Friday
• Status: Temporary Full-Time (19 Months Contract)
• Closing Date: August 28, 2026

Position Summary

The Tumor Immunotherapy Program at Princess Margaret Cancer Centre is the first program of its kind in Canada and one of only a handful of others around the world. The program brings together specialists in the fields of immunology, oncology, pathology and surgery who have expertise spanning from basic immunology discoveries through clinical trials of immune therapies. The Tumor Immunotherapy Program is focused on improving our knowledge of the immune system to better diagnose, detect and target cancers.

The Clinical Study and Regulatory Specialist participates in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow up and trial closure.

This position is an 19‑month term, temporary full‑time contract, with the possibility of renewal for additional years, subject to performance, funding availability, and program requirements.

Duties

• Preparation of Health Canada and Research Ethics Board submissions
• Monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs). The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice.
• All data must be complete, accurate, timely, and must follow applicable ICH‑GCP, FDA and US federal code and Tri‑Council regulations.
• The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.
• Executes study‑related administrative tasks, such as maintenance and modification of study‑specific trackers and study tools, collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic formats

Requirements

• At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science‑Related Discipline required
• At least two (2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects required
• At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions, including writing informed consent forms
• Demonstrated relevant clinical research knowledge
• 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
• Satisfactory attendance
• Certification as a Clinical Research Professional, preferred

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(HOOPPhttps://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.

Please be advised that a Criminal Record Check may be required of the successful candidate.