Clinical Study & Regulatory Specialist I - UHN, Toronto

The Opportunity

Join the University Health Network (UHN), a leading healthcare institution in Toronto, for a vital role within the Princess Margaret Cancer Centre. The Tumor Immunotherapy Program, the first of its kind in Canada, brings together specialists in immunology, oncology, pathology, and surgery. This innovative program spans basic immunology discoveries through advanced clinical trials of immune therapies, with a core focus on improving our understanding of the immune system to better diagnose, detect, and target cancers.

As a Clinical Study and Regulatory Specialist I, you will play a crucial role in coordinating clinical trials from initial protocol review and regulatory approval through to activation, ongoing follow-up, and eventual trial closure. This temporary full-time contract offers an exceptional opportunity to contribute to cutting-edge health research in a dynamic environment, with potential for renewal based on performance and program needs.

What You'll Do

• Prepare Health Canada and Research Ethics Board submissions.
• Monitor and promote the quality and integrity of data, accurately recording clinical trial data in case report forms (CRFs).
• Coordinate and monitor data in accordance with trial protocols, hospital and departmental guidelines, and professional standards of practice.
• Ensure all data is complete, accurate, timely, and compliant with applicable ICH-GCP, FDA, US federal code, and Tri-Council regulations.
• Interpret applicable regulatory guidelines to ensure full compliance.
• Utilize quality assurance procedures to obtain high-quality data.
• Execute study-related administrative tasks, including maintaining and modifying study-specific trackers and tools.
• Collect and maintain regulatory documents, ethics submissions, protocols, staff training, and delegation logs in both paper and electronic formats.

Requirements

• Completion of a Bachelor’s degree program, or recognized equivalent in a Health or Science-Related Discipline.
• At least two (2) years of experience in some or all of Oncology, Clinical trials, medical terminology, and regulatory issues involving human subjects.
• At least one (1) year of 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 and prioritization skills.
• Good computer skills.
• Ability to learn quickly and work independently.
• Excellent interpersonal skills.
• Ability to work under pressure and strong attention to detail.
• Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines in accordance with 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.

Benefits

Joining University Health Network means becoming part of a world-renowned institution that values its employees. UHN offers a comprehensive range of benefits, programs, and perks designed to support your well-being and career growth, making it a differentiating factor for healthcare jobs in Toronto.

• Competitive offer packages.
• Membership in the Healthcare of Ontario Pension Plan (HOOPP).
• Close access to transit and UHN shuttle service.
• A flexible work environment.
• Opportunities for development and promotions within a large organization.
• Additional perks including multiple corporate discounts (travel, restaurants, parking, phone plans, auto insurance), and on-site gyms.