Clinical Study and Regulatory Specialist I

University Health Network; Toronto; On-site; 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 dynamic team. This role involves coordinating clinical trials, ensuring data integrity, and complying with regulatory standards. The ideal candidate will have a strong background in oncology and clinical research, demonstrating excellent communication and organizational skills. Join a leading research hospital dedicated to advancing healthcare and making a significant impact in patient care. This is a fantastic opportunity for those passionate about clinical research and looking to grow in a supportive environment.

Benefits

Comprehensive Benefits Package

Pension Plan

Transit Access

Flexible Work Environment

Development Opportunities

Discounts

On-Site Amenities

Qualifications

• Bachelor’s degree in a health or science-related discipline is required.
• Two years of experience in oncology or clinical trials is essential.

Responsibilities

• Coordinate clinical trials from protocol activation to closure.
• Monitor data quality and ensure compliance with regulations.

Skills

Oncology

Clinical Trials

Medical Terminology

Regulatory Issues

Communication Skills

Attention to Detail

Client Service Orientation

Education

Bachelor's Degree in Health or Science

Clinical Research Graduate Certificate

Tools

Data Management Software

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 the 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.

Position Details

• Union: Non-Union
• 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
• Salary: $66,924– $83,655 annually (to be commensurate with experience and consistent with UHN compensation policy)
• 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 compiling ethics and regulatory documents.
• Coordinating and monitoring data in accordance with the trial protocol, hospital and departmental guidelines, and professional standards of practice.
• Assessing, compiling, recording, and submitting data to pharmaceutical companies or for internal studies.
• Ensuring all data is complete, accurate, timely, and compliant with applicable ICH-GCP, FDA, US federal code, and Tri-Council regulations.
• Interpreting applicable regulations to ensure compliance and utilizing quality assurance procedures to obtain high-quality data.

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 of 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 tasks concurrently
• Knowledge of applicable legislative, UHN, and departmental policies
• Client service orientation and ability to work effectively with diverse backgrounds
• Satisfactory attendance

UHN offers a comprehensive benefits package, including competitive salary, pension plan, transit access, flexible work environment, development opportunities, and various perks such as discounts and on-site amenities.

Current employees must have completed probation and have a satisfactory record 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 inaccurate information may result in application disqualification.

UHN is committed to diversity and inclusion. Requests for accommodation can be made at any stage of the process.

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