Clinical Study Regulatory Specialist I

Universityhealthnetwork; Toronto; On-site; CAD 70,000 - 88,000; Full time

Benefits offered by this job

Competitive offer packages

HOOPP pension plan

Transit access

Flexible work environment

Development opportunities

Corporate discounts

Job summary

University Health Network seeks a Clinical Study and Regulatory Specialist I to coordinate oncology trials from protocol activation to closure, ensuring data integrity at Princess Margaret Cancer Centre. You will prepare ethics submissions, CRFs, and regulatory documents, and ensure compliance with ICH-GCP, FDA, and Tri-Council standards.

Required are a health/science degree and 2+ years in clinical trials, with strong written/verbal communication and attention to detail.

Qualifications

• Bachelor's degree in health or science required; Clinical Research Graduate Certificate preferred.
• At least two years of experience in oncology, clinical trials, regulatory issues with human subjects.
• Experience with Health Canada and Research Ethics Board submissions; informed consent forms.

Responsibilities

• Coordinate clinical trials from protocol activation to closure.
• Monitor data quality; record CRFs and compile ethics/regulatory documents.
• Data submission to sponsors or internal studies per protocol.
• Ensure compliance with ICH-GCP, FDA, and Tri-Council regulations.
• Apply QA procedures to obtain high-quality data.

Skills

Data quality

Regulatory awareness

Communication

Organization

Attention to detail

Time management

Independent work

Interpersonal skills

Education

Bachelor's degree in health or science

Clinical Research Graduate Certificate

Job description

Union : Non-Union

Number of Vacancies: 1

Site : Princess Margaret Cancer Centre

Department: Division of Medical Oncology and Hematology - Clinical Trials Group

Reports to: Clinical Research Manager, DMOH-CTG

Salary Range: $70,473 - $88, 101 per annum

Hours: 37.5 hours per week

Shifts : Monday - Friday

Status: Permanent Full-time

Closing Date : December 09, 2026

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 must be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations.
• Interpret the applicable regulations in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

Qualifications and Experience:

• At minimum, a Bachelor's degree in a health or science-related discipline (required) Clinical Research Graduate Certificate (preferred)
• At least two (2) years experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
• At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions, including writing informed consent forms
• Demonstrated relevant clinical research knowledge
• Excellent written and verbal communication skills, excellent organization, prioritization skills, good 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 in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
• Ability to perform multiple concurrent tasksKnowledge of applicable legislative, UHN and/or departmental policies
• Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand
• Satisfactory attendance
• Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.
• Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

Why join UHN?

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/ )
• Close access to Transit and UHN shuttle service
• A flexible work environment
• Opportunities for development and promotions within a large organization
• Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

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