Clinical Study and Regulatory Specialist I

University Health Network; Toronto; Hybrid; CAD 66,000 - 84,000; Full time

Job summary

An established industry player is seeking a Clinical Study and Regulatory Specialist I to join their innovative Drug Development Program. This role involves coordinating clinical trials, ensuring compliance with regulations, and collaborating with various stakeholders. The successful candidate will have a strong background in oncology and clinical trials, coupled with excellent communication and organizational skills. This temporary full-time position offers a hybrid work model and competitive salary, making it an exciting opportunity for those looking to make a significant impact in the healthcare field.

Benefits

Competitive packages

Membership in HOOPP

Accessible transit options

Flexible work environment

Opportunities for growth and promotion

Various discounts and on-site amenities

Qualifications

• 1-2 years’ experience in oncology or clinical trials.
• Knowledge of Health Canada regulatory submissions.

Responsibilities

• Coordinate studies from activation to close-out.
• Ensure compliance with trial protocols and regulations.
• Monitor data and prepare submissions to Health Canada.

Skills

Oncology

Clinical Trials

Medical Terminology

Regulatory Issues

Communication Skills

Organizational Skills

Attention to Detail

Education

Bachelor’s degree in Health or Science

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
• 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
• Salary: $66,924 - $83,655 (To be commensurate with experience and consistent with UHN compensation policy)
• 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, emphasizing pharmacokinetics, translational studies, and Investigator Initiated Trials, using a collaborative and multidisciplinary approach for rapid, high-quality study completion.

Duties:

• Coordinate studies from activation to close-out
• Ensure data collection and monitoring adhere to trial protocol, 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 codes, 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 or recognized equivalent in Health or Science related discipline
• 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 work independently and under pressure
• Attention to detail and professional conduct
• Ability to manage multiple tasks concurrently
• Knowledge of applicable legislative, UHN, and departmental policies
• Client service orientation and appreciation for diversity
• Satisfactory attendance
• Certification as a Clinical Research Professional preferred

UHN offers competitive benefits, development opportunities, and perks, including:

• Competitive packages
• Membership in HOOPP
• Accessible transit options
• Flexible work environment
• Opportunities for growth and promotion
• Various discounts and on-site amenities

Applicants must have completed probation and have a good employee record. All applications should be submitted before the closing date. UHN communicates via email; please check regularly. A Criminal Record Check may be required. Misleading or incorrect information may disqualify candidates. UHN is committed to diversity and inclusion, and accommodations are available upon request.

We thank all applicants for their interest; only those selected for further consideration will be contacted.