Clinical Study and Regulatory Specialist I

Uhnresearch; Toronto; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Study and Regulatory Specialist to join their dynamic team at the Princess Margaret Cancer Centre. This role offers the unique opportunity to work within Canada's largest new drug development program, focusing on innovative and impactful research in oncology. You will coordinate clinical trials, ensuring adherence to protocols and regulatory standards while collaborating with a multidisciplinary team. If you are passionate about advancing healthcare through research and thrive in a fast-paced environment, this position is perfect for you. Join a forward-thinking organization dedicated to building a healthier world.

Benefits

Competitive Packages

Benefits

Opportunities for Development

On-site Amenities

Discounts

Qualifications

• Bachelor's degree in Health or Science-related discipline required.
• 1-2 years' experience in Oncology or Clinical Trials preferred.

Responsibilities

• Coordinate studies from activation to close-out.
• Ensure compliance with trial protocols and regulations.
• Prepare submissions to Health Canada and Research Ethics.

Skills

Oncology

Clinical Trials

Medical Terminology

Regulatory Issues

Data Collection

Communication Skills

Organization Skills

Interpersonal Skills

Education

Bachelor’s Degree in Health or Science-related Discipline

Job description

Clinical Study and Regulatory Specialist I

• Contract
• Department: Research

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
Site: Princess Margaret Cancer Centre
Department: BRAS Drug Development Program - Phase II
Reports to: Clinical Research Manager
Work Model: Hybrid
Hours: 37.5 Hours Per Week
Shifts: Day Shift
Status: Temporary Full-time
Closing Date: May 14, 2025

Position Summary:

The Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only centre outside of the United States to have a contract with the NIH. The program includes a Phase II focus on pharmacokinetics, translational studies, and Investigator Initiated Trials, employing a collaborative and multidisciplinary approach to ensure rapid, high-quality study completion.

Duties:

• Coordinate studies from activation to close-out
• Ensure data collection and monitoring adhere to trial protocols, hospital and departmental guidelines, and professional standards
• Collect and abstract data from source documents
• Monitor data and prepare submissions to Health Canada and Research Ethics
• Ensure all data is complete, accurate, timely, and compliant with ICH-GCP, FDA, US federal code, and Tri-Council regulations
• Interpret applicable regulations to ensure compliance
• Handle study-related administrative tasks
• Collaborate with cooperative groups, pharmaceutical companies, or for internal studies

Minimum Qualifications:

• Completion of a Bachelor’s degree in Health or Science-related discipline or recognized equivalent
• 1-2 years’ experience in Oncology, Clinical trials, medical terminology, or regulatory issues involving human subjects
• Experience with Health Canada regulatory submissions and site management
• Relevant clinical research knowledge
• Excellent communication, organization, prioritization, and computer skills; ability to learn quickly and work independently
• Strong interpersonal skills
• Ability to work under pressure and with attention to detail
• Professional and courteous conduct, high-quality work, and meeting deadlines
• Ability to handle multiple tasks concurrently
• Knowledge of legislative, UHN, or departmental policies
• Client service orientation and appreciation for diversity
• Satisfactory attendance
• Certification as a Clinical Research Professional preferred

UHN offers competitive packages, benefits, and opportunities for development within a large organization, including discounts and on-site amenities. Current employees must complete probation and maintain satisfactory attendance. Applications close on the specified date, and communication will be via email. A Criminal Record Check may be required. UHN is committed to equity and inclusion, accommodating requests at any recruitment stage. Only selected applicants will be contacted. We thank all for their interest.