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 offers the opportunity to coordinate clinical trials, ensuring data integrity and compliance with regulatory standards. You will work in a supportive environment that values research and innovation, contributing to groundbreaking studies in oncology. The ideal candidate will possess strong communication skills, a keen eye for detail, and a passion for improving patient care through research. Join a leading institution dedicated to building a healthier world and make a meaningful impact in the field.

Benefits

Comprehensive benefits package

Pension plan

Transit access

Flexible work environment

Development opportunities

Various discounts and perks

Qualifications

• 2+ years of experience in Oncology and Clinical Trials.
• Strong knowledge of Health Canada and Research Ethics Board submissions.

Responsibilities

• Coordinate clinical trials from protocol activation to closure.
• Ensure compliance with ICH-GCP, FDA, and Tri-Council regulations.

Skills

Oncology

Clinical Trials

Medical Terminology

Regulatory Issues

Communication Skills

Organization Skills

Attention to Detail

Client Service Orientation

Education

Bachelor’s degree in health or science-related discipline

Clinical Research Graduate Certificate

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
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 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 compilation of ethics and regulatory documents.
• The coordination and monitoring of data are 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 of experience in review and preparation of 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 skills, computer skills, ability to learn quickly, and work independently
• Excellent interpersonal skills
• Ability to work under pressure and attention to detail
• Ability to perform duties professionally and courteously, producing high-quality work while meeting deadlines in accordance with UHN standards
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative, UHN, and departmental policies
• Client service orientation, with the ability to work effectively with diverse backgrounds and perspectives
• Satisfactory attendance

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

Current UHN employees must have completed their probationary period and maintained a good employee 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 an equal opportunity employer committed to diversity and inclusion. Accommodation requests can be made at any stage.

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