Clinical Research Associate II (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time 2025-13167

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 Clinical Trials Manager Operations Manager and Budget & Operations Coordinator work with 35 physicians actively participating in clinical research and 55 clinical research staff. Our program is comprised of 12 disease site groups; Breast CNS NETS GI GU medical GU radiation Gynecology Head & Neck Hematology Lung Melanoma and Personalized Medicine; as well as 2 panCanadian initiatives (Personalize My Treatment & The Canadian Cancer Clinical Trials Network (3CTN)).

The goal of this Clinical Research Associate (CRA) II position is to assist the Head & Neck Oncology Disease Site Group with the maintenance of their active oncology clinical research studies databases and clinical trials. This position is for a fulltime position working weekdays (8hr) onsite at Sunnybrook Bayview campus. This position is entitled to health benefits plan pension and paid time off/sick days.

The goal of this position is to assist with our Head & Neck Disease Site Group with the maintenance of several complex ongoing clinical trials with a split focus on patientfacing responsibilities and protocol activation of new clinical trials. Primary responsibilities include but are not limited to consenting patients reviewing trial eligibility criteria; ongoing patient protocol requirements; reporting Adverse Events/Serious Adverse Events; scheduling patient appointments; conducting measurements on patients including vital signs height/weight measurements and ECG tests; communication with various hospitals and health service facilities to obtain medical information; data entry and resolving sponsor queries; completing forms and maintaining supportive documentation; and processing blood urine or tissue specimens.

In addition the CRA II will dedicate part of their time to supporting Protocol Activation activities complete REB submissions conduct impact assessment and communication with internal hospital departments coordinate with the budget coordinator liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals to manage the trial master file and applicable documents SIV coordination and other activationrelated activities.

The CRA II will be based onsite and will report to the Site Lead and PIs also working closely with an interdisciplinary team including the Clinical Trials Manager Operations Manager and all other OCC Clinical Research Program staff. The position will be a regular fulltime position entitled to paid vacation & sick time health benefits package and HOOPP pension. This position may require walking between depts across Sunnybrook Bayview campus.

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

Qualifications/Skills:

• Requires the successful minimum completion of a Bachelors degree or recognized equivalent in a health or sciencerelated discipline with a minimum of 35 years clinical and/or professional experience including at least 3 years clinical researchrelated experience
• Oncology clinical trial experience and/or Interventional Health Canada Regulated trial experience highly preferred
• SoCRA/CCRP certification an asset
• Welldeveloped organizational and time management skills
• Demonstrated knowledge of ICH guidelines Good Clinical Practice Division 5 21CFR11
• Proven experience in processing and shipping blood samples
• Knowledge and experience in the clinical trial protocol activation process
• Familiarity with the Trial Master File and management of trialrelated documents
• Experience preparing/submitting research documents to research ethics boards
• Excellent oral and written communication skills
• Ability to follow established trial protocols guidelines procedures and standards
• Demonstrated ability to work collaboratively in a team environment
• Ability to take responsibility in meeting multiple deadlines and making progress on multiple projects with direct and indirect supervision
• Strong analytical skills with close attention to detail
• Experience in data collection data entry and query resolution using electronic data capture systems
• Intermediate to advanced skills with MS Office software (Outlook Word Excel PowerPoint)
• Experience with medical terminology and patientfacing communication including obtaining AE/SAE or other trialrelated medical information
• Experience with the informed consent process and experience consenting patients to clinical trials
• Satisfactory attendance

Application screening will continue until a suitable candidate is identified. If your expertise qualifies you for this challenging fulltime position please apply below.

Please submit your resume with your First and Last name in the file name.