Clinical Research Associate II; SRI - Odette Cancer Centre Clinical Trials - Regular

Summary Of Duties And Responsibilities

The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to conduct innovative and high‑quality clinical research. Working with over 35 physicians and 55 OCC clinical research disease‑site‑specific staff across 12 disease groups (Breast, CNS, NETS, GI, GU medical, GU radiation, Gynecology, Head & Neck, Hematology, Lung, Melanoma, Early Phase I‑II trials) and the Canadian Cancer Clinical Trials Network (3

CTN), this role supports the GU Med Oncology Disease Site Group in maintaining active oncology clinical research studies, databases, and trials.

This full‑time position is located on‑site at Sunnybrook, Bayview campus and includes a health benefits plan, pension contribution, and paid time off. The CRA II reports to the team Physician Site Lead, the team Supervisor, and principal investigators, and works closely with the Clinical Trials Manager, Operations Leads, and other OCC Clinical Research Program staff.

• Lead the management of several complex Health Canada‑regulated interventional clinical trials, academic clinical trials, and other research projects independently
• Request, handle, and process laboratory specimens (blood, urine, tissue)
• Consent patients, review trial eligibility criteria, and assess medical records
• Apply clinical trial protocol requirements to patient‑ and data‑related activities, including documenting medical history, medications, and adverse events, and reporting Serious Adverse Events
• Schedule and conduct patient appointments, complete quality‑of‑life questionnaires, and perform measurements (vital signs, ECG, height/weight)
• Communicate with hospitals and health service facilities to obtain medical information
• Understand ethics review requirements, complete REB submissions, and update documentation
• Perform data entry and resolve sponsor queries
• Schedule and participate in monitoring visits, sponsor audit visits, and regulatory inspections
• Maintain documentation as part of the trial master file and create source documents
• Communicate with internal hospital departments or liaise with Contract Research Organizations (CROs) and sponsors on behalf of principal investigators
• Track trial metrics and other research‑related activities within team needs
• Lead activation activities of new clinical trials with external sponsors and CROs, and the closure of completed trials

• Minimum completion of a Community College Diploma/Certificate or University Degree in a health‑related discipline
• 3–5 years of related professional or practical experience, including at least 3 years in clinical research, or equivalent combination of education and experience;
  Health Canada‑regulated clinical trial experience preferred
• SoCRA/CCRP certification an asset; oncology clinical trial experience an asset
• In‑depth knowledge of ICH guidelines, Good Clinical Practice, and transport of dangerous goods
• Proven experience in processing and shipping blood samples
• Experience in the informed consent process and working directly with research participants
• Ability to understand and apply clinical trial protocols and laboratory manuals
• Knowledge and experience in the ethics review and submission process
• Strong MS Office skills and ability to adapt to new online systems and applications, accurately entering data and resolving queries (EDC databases, document portals)
• Experience maintaining clinical trial documentation in a Trial Master File and creating source documentation
• Experience in patient‑facing communication, including obtaining AE/SAE or other trial‑related medical information
• Familiarity with medical terminology or experience reviewing patient health records
• Experience or familiarity with research contracts and budget management an asset
• Ability to train new team members or assist junior staff on the team

• Well‑developed organizational and time‑management skills
• Excellent teamwork with a strong “can‑do” attitude to build working relationships
• Excellent oral and written communication skills; professional communication across…