Clinical Research Associate I (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time 2025-13168

Summary of Duties and Responsibilities:

The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institutes (SRI) ongoing commitment to participate in innovative and high quality clinical research.

Within OCC Clinical Research the Research and Medical Directors Clinical Trials Manager Operations Manager and Budget & Operations Coordinator work with 35 physicians actively participating in clinical research and 45 OCC clinical research disease sitespecific staff. Our program is comprised of 10 disease site groups; Breast CNS/NETs GI GU Gynecology Head & Neck Hematology Lung and Melanoma in addition to Personalized Medicine.

The goal of this position is to assist one of our Gynecology Oncology Disease Site Group with the maintenance of several ongoing research studies with a focus on data documentation sample processing and patientspecific responsibilities. This is an onsite position MondayFriday at Sunnybrook Bayview campus.

Primary responsibilities include but are not limited to:

• Requesting handling and/or processing laboratory specimens (blood urine tissue)
• Consenting patients reviewing trial eligibility criteria and medical records
• Ongoing patient protocol requirements
• Reporting Adverse Events/Serious Adverse Events
• Scheduling patient appointments & completing qualify of life questionnaires with patients
• Conducting measurements on patients including vital signs height/weight measurements
• Communication with various hospitals and health service facilities to obtain medical information
• Data entry and resolving sponsor queries
• Scheduling and participating in monitoring visits
• Maintaining documentation as part of the trial master file
• Communication with internal hospital departments or liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals
• Tracking of trial metrics and other researchrelated activities within the needs of the team
• The CRA I will be based onsite and will report to the team Physician Site Lead team Supervisor and CRA I may also work closely with an interdisciplinary team including the Clinical Trials Manager Operations Manager and all other OCC Clinical Research Program staff.

The successful candidate will be an eager team player who meets the following qualifications/skills:

• Requires the successful minimum completion of a Bachelors degree or recognized equivalent in a health or sciencerelated discipline with 23 years clinical and/or professional experience including 1 year clinical researchrelated experience or equivalent combination of education and experience; oncology research experience an asset
• Oncology patient experience preferred
• SoCRA/CCRP certification an asset
• Welldeveloped organizational and time management skills
• Indepth knowledge of ICH guidelines and Good Clinical Practice
• Proven experience in processing and shipping blood samples
• Familiarity with the Trial Master File and management of trialrelated documents
• Ability to follow established trial protocols guidelines procedures and standards
• Ability to effectively manage multiple projects with competing deadlines
• Excellent oral and written communication skills
• Demonstrates excellent team work and efficient independent work habits
• Proven experience taking initiatives Strong analytical skills with close attention to detail
• Experience in data collection data entry and query resolution using electronic data capture systems
• Working knowledge of word processing spreadsheet and database software packages such as MSOffice
• Familiarity with medical terminology and patientfacing communication including obtaining AE/SAE or other trialrelated medical information
• Familiarity with the informed consent process and experience consenting patients to clinical trials or research studies
• Acceptable attendance