Clinical Study and Regulatory Specialist I

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 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 Qualifications 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 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. 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 35.35 - CAD 54.03 - hourly

The specialist coordinates clinical trials from protocol review and regulatory approval through to activation, follow-up, and closure. They are responsible for maintaining regulatory documents, ensuring data integrity, and managing ethics submissions in compliance with applicable regulations.

Candidates must hold at least a Bachelor's degree in a health or science-related discipline. A minimum of two years of experience in oncology or clinical trials, including regulatory submission preparation, is required.

• 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

• Quality assurancePreferred
• Attention to detailPreferred

Identified from the job description. Confirm important requirements above.

• Clinical trials
• Regulatory affairs
• Health Canada submissions
• Research Ethics Board submissions
• Informed consent forms
• Data management
• Quality assurance
• Oncology
• Medical terminology
• ICH-GCP
• FDA regulations
• Administrative support
• Communication skills
• Organization skills
• Attention to detail
• Informed Consent
• Regulatory Documents
• Ability To Meet Deadlines
• Ethical Standards And Conduct
• Administrative Functions
• Quick Learning
• Research
• Artificial Intelligence
• Medical Research
• Management
• Cancer
• Cardiology
• Immunology
• Clinical Research
• Clinical Trials
• Computer Literacy
• Case Report Forms
• Pathology
• Human Subject Research
• Good Clinical Practices (GCP)
• Immunotherapy
• Innovation
• Infectious Diseases
• Interpersonal Communications
• Medical Terminology
• Rehabilitation
• Physical Medicine And Rehabilitation
• Quality Assurance
• Surgery
• Verbal Communication Skills
• Writing
• Coordinating
• Prioritization
• Detail Oriented

• Healthcare
• Science & Research
• Administrative
• Clinical Regulatory Specialist
• Regulatory Affairs Specialist
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Specialists
• Compliance Officers

Minimum education

Bachelor’s degree

Minimum experience

2+ years

Apply by

Aug 29, 2026

Posting language

English

Working hours

38 hours per week