Clinical Study and Regulatory Specialist I

Uhnresearch; Toronto; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Study and Regulatory Specialist I to join their dynamic team. This role involves coordinating clinical trials, ensuring data integrity, and complying with regulatory standards. You will play a crucial part in the research process, contributing to groundbreaking studies that impact patient care. The organization offers a supportive environment with opportunities for professional development and a comprehensive benefits package. If you are passionate about clinical research and looking to make a difference in healthcare, this position is perfect for you.

Benefits

Competitive Salary Packages

Membership in HOOPP

Access to Transit Services

Flexible Work Environment

Opportunities for Development

Corporate Discounts

On-Site Gyms

Qualifications

• 2+ years of experience in Oncology and clinical trials.
• Strong knowledge of ICH-GCP and FDA regulations.

Responsibilities

• Coordinate clinical trials from protocol activation to closure.
• Ensure compliance with regulatory guidelines and quality assurance.

Skills

Oncology

Clinical Trials

Medical Terminology

Regulatory Issues

Communication Skills

Organizational Skills

Attention to Detail

Education

Bachelor’s Degree in Health or Science

Clinical Research Graduate Certificate

Tools

Case Report Forms (CRFs)

Health Canada Submissions

Job description

Clinical Study and Regulatory Specialist I

• Full-time
• 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: 2
Site: Princess Margaret Cancer Centre
Department: Division of Medical Oncology and Hematology – Clinical Trials Group
Reports to: Clinical Research Manager, DMOH-CTG
Work Model: On-Site
Hours: 37.5 hours per week
Shifts: Monday - Friday
Status: Permanent Full-time
Closing Date: May 14, 2025

Position Summary: The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol activation and follow-up to trial closure.

Duties:

• Monitoring and promoting the quality and integrity of data, recording clinical trial data in case report forms (CRFs), and compilation of ethics and regulatory documents.
• The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines, and professional standards of practice.
• Data is assessed, compiled, recorded, and submitted to pharmaceutical companies or used for internal studies.
• All data must be complete, accurate, timely, and in compliance with applicable ICH-GCP, FDA, US federal code, and Tri-Council regulations.
• Interpret the applicable regulations to ensure compliance. Quality assurance procedures are utilized to ensure high-quality data is obtained.

Minimum Qualifications:

• Bachelor’s degree in a health or science-related discipline (required)
• At least two (2) years of experience in Oncology, Clinical trials, medical terminology, or regulatory issues involving human subjects
• At least one (1) year experience in reviewing and preparing Health Canada and Research Ethics Board submissions, including writing informed consent forms
• Clinical Research Graduate Certificate (preferred)
• Demonstrated relevant clinical research knowledge
• Excellent written and verbal communication skills, organization, prioritization, computer skills, ability to learn quickly, and work independently
• Excellent interpersonal skills
• Ability to work under pressure and attention to detail
• Professional and courteous manner, producing high-quality work within deadlines
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative, UHN, and departmental policies
• Client service orientation, with appreciation for diversity
• Satisfactory attendance

UHN offers a comprehensive benefits package, including:

• Competitive salary packages
• Membership in the Healthcare of Ontario Pension Plan (HOOPP)
• Access to transit and shuttle services
• Flexible work environment
• Opportunities for development and promotion
• Additional perks such as corporate discounts, on-site gyms, and more

Current employees must have completed probation and maintained satisfactory attendance to be eligible.

All applications must 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 result in application discontinuation.

UHN is an equal opportunity employer committed to diversity and inclusion. Accommodation requests can be made at any recruitment stage.

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