Clinical Study and Regulatory Assistant

Company Description

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.

Job Description
Union: Non-Union

Site: Hydro Place - 700 University Avenue

Department: Research

Reports to: Clinical Research Manager- DDP2

Work Model: Hybrid

Job Code: 2909

Hours: 37.5 Hours Per Week

Salary: $52,182 - $65,228 Per Annum (To commensurate with experience and consistent with UHN compensation policy)

Status: Permanent Full-Time

Closing Date: April 23, 2025

Job Summary

The Drug Development Program at Princess Margaret Cancer Centre is the largest new drug development program in Canada and the only center outside of the United States to have a contract with the National Institutes of Health (NIH). The Drug Development Program includes a Phase II program, focusing on studies across the various phases of trials with a strong emphasis on pharmacokinetics, translational studies and Investigator Initiated Trials. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high quality studies.

Duties

• Assist with the day to day coordination and administrative tasks for research studies.
• May assist with study start-up and close out including filing and sorting through source documentation.
• Performs data transcription from health records or other sources, as per approved study protocol, assists with collecting and redacting source.
• May assist in the preparation of submissions to the Research Ethics Board.
• Assists Study coordinators by obtaining signatures, maintaining study trackers, collecting CVs, Medical Licenses & Training documents.
• Performs administrative tasks such as room bookings, supply ordering, maintaining timesheets, lab licenses, study trackers, administrative binders.

Qualifications

• At a minimum Community college diploma in a health related discipline, or equivalent required
• Minimum 3 to 6 months clinical research related experience
• Demonstrated relevant knowledge of clinical research and of human research regulations and guidelines of applicable legislative, UHN and/or departmental policies.
• Certification as a Clinical Research Professional, preferred
• Knowledge of Research regulations and guidelines (such as ICH/GCP, Tri-Council Policy, Declaration of Helsinki, FDR, CFR and Health Canada TPD as required)
• Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
• Ability to work under pressure, strong attention to detail, ability to perform multiple concurrent tasks
• Proficiency with MS Office software
• Adheres to confidentiality policy for sensitive patient data and information
• Excellent interpersonal skills
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
• Knowledge 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.

Additional Information
Why join UHN?

In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP)
• 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.)

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.

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.

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.

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.