Clinical Research Analyst

University Health Network • Toronto, ON

6d • CA$34 - CA$42 • Onsite

About The Position

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 Analyst will support the conduct and management of clinical trials, assist in facilitating and coordinating daily study activities, and play a critical role in the overall execution of the study.

Requirements

• 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, 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

Nice To Haves

• clinical trial research experience is preferred

Responsibilities

• 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

Benefits

• 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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level