Clinical Research Study Assistant

Union: Non-Union
Number of vacancies: 1
Site: Toronto Western Hospital
Department: The Rheumatology Clinical Trials Unit
Reports to: Principal Investigator
Hours: 37.5 hours per week
Shifts: Day
Status: Temporary Full-time
Closing Date: December 31, 2025

Position Summary
The Rheumatology Clinical Trials Unit at the Toronto Western Hospital/Schroeder Arthritis Institute is seeking a highly motivated individual to join our team. We are a busy clinical trial unit with a focus on Systemic Lupus Erythematosus, Psoriatic Arthritis, Osteoarthritis, Rheumatoid Arthritis and Sjogren’s Syndrome trials. Working under supervision of multiple principal investigators, the Clinical Research Study Assistant will assist in conduct, and management of clinical trials. The CDRC will assist in facilitating and coordinating daily clinical trial activities and plays a critical role in the conduct of the study.

Duties
Working under the directions of the Director of the Rheumatology Clinical Trial Unit, Clinical Research Manager and other senior research staff members, the Clinical Research Study Assistant's responsibilities include but are not limited to:

• Prepare, submit, and maintain Research Ethics Board (REB) applications, track ethics approvals, and regulatory submissions during and post study conduct, including but not limited to, SAEs, End of Study Notifications, Amendments, Renewals, responses to other submissions queries/questions/observations, etc.
• Prepare regulatory documents for REB submission
• Prepare Investigator site file binders as per sponsor policies
• Assist in study participant recruitment by identifying and screening potential subjects, obtaining informed consent, conducting pre-testing, and administering questionnaires or other data collection tools
• Assist in data collection, source documentation and data entry following UHN policy and ICH/GCP guidelines
• Identify problems using assessment skills and report any abnormalities to the Clinical Research Manager
• Execute study-related administrative tasks, including the collection of regulatory documents and ethics submissions
• Conduct telephone and/or clinical recruitment interviews
• Perform various study-related tasks during study visits, such as basic administration, collecting, processing and shipping samples according to the trial protocol, archiving close-out studies, lab kit disposal and IP destruction

• At minimum, a Community college diploma in a health-related discipline, or equivalent is required
• Bachelor's degree or recognized equivalent, in health related field or science-related discipline is preferred
• At Minimum, 3 to 6 months of related experience is required; clinical trial research experience preferred
• Understanding of ICH-GCP guidelines, TCPS2 standards, and Health Canada regulations
• Experience with electronic data capture systems (Medidata Rave, Veeva Vault, RedCap) and skilled in query resolution and data quality assurance
• Understanding of study protocols, case report forms (CRFs), and source documentation
• Ability to coordinate with nurses, physicians, pharmacists, and study coordinators
• Experience with lab techniques, sample handling, and safety protocols
• Attention to detail and commitment to maintaining data integrity and confidentiality
• Ability to work independently and collaboratively in a fast-paced environment
• Ability to multi-task and perform in a fast-paced environment
• Excellent interpersonal, verbal and written communication skills, required
• Proficiency with MS Office software (Outlook, Word, Excel, PowerPoint)
• Excellent organizational and time management skills
• Well-developed critical reasoning skills
• 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

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 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.)

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.