Clinical Research Analyst - University Health Network, Toronto

Position Summary

The Rheumatology Clinical Trials Unit at Toronto Western Hospital/Schroeder Arthritis Institute, part of the University Health Network (UHN), is actively seeking a highly motivated Clinical Research Analyst. This busy clinical trial unit focuses on critical studies related to Systemic Lupus Erythematosus, Psoriatic Arthritis, Osteoarthritis, Rheumatoid Arthritis, and Sjogren’s Syndrome. Working under the supervision of multiple principal investigators, the Clinical Research Analyst will be instrumental in supporting the conduct and management of these vital clinical trials. This role involves facilitating and coordinating daily study activities, playing a critical part in the overall execution of each research study.

Day-to-Day Responsibilities

Working under the guidance of the Director and co-Director of the Rheumatology Clinical Trial Unit, the Clinical Research Manager, and other senior research staff, the Clinical Research Analyst will undertake a variety of essential tasks. These responsibilities are crucial for the smooth operation and compliance of all ongoing clinical trials and research studies.

• Prepare, submit, and maintain Research Ethics Board (REB) applications, tracking ethics approvals and regulatory submissions during and post study conduct, including but not limited to, SAEs, End of Study Notifications, Amendments, Renewals, and responses to other submissions queries/questions/observations.
• 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.

Requirements and Qualifications

To excel in this Clinical Research Analyst role within the Rheumatology Clinical Trials Unit at UHN, candidates should possess a strong foundation in health or science-related disciplines and relevant experience. The position demands meticulous attention to detail, strong organizational skills, and the ability to work effectively in a fast-paced clinical research environment, ensuring data integrity across all trials.

• Bachelor’s degree, or recognized equivalent, in a health or science-related discipline.
• At minimum, 1 to 2 years of related experience is required; clinical trial research experience is 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.
• 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.

Perks and Benefits at UHN

Joining the University Health Network (UHN) means becoming part of an inspiring healthcare community and gaining access to a comprehensive suite of benefits, programs, and perks designed to support your well-being and career growth. UHN's offerings are a differentiating factor, providing value throughout your tenure, making it an attractive choice for healthcare jobs in Toronto.

• 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.).