Clinical Research Associate – Oncology Clinical Trials
Southlake Regional Health Centre
The Clinical Research Associate is responsible for the organization, co-ordination and ongoing conduct of assigned clinical research trials. This person will prepare, and collect required documentation across the continuum of all Clinical Research studies while ensuring accurate, concise and timely submission of documentation to sponsoring Canadian, American and International agencies.
• Post Secondary education in a Health Science field of study is required
• Bachelor of Science (BSc.) preferred
• Clinical Research Associate Certificate required
• National Institute of Health (NIH) research participants Web course preferred
• Minimum 2 years related experience, in a clinical research setting, or equivalent combination of education and experience.
• At minimum, 2 years experience in clinical research conducting clinical trials, registering eligible patients, and interacting with patients and their families following patient-centered care model.
• Minimum of 2 years experience explaining details and requirements of the trial design to patients and or family.
• Advanced knowledge of the current regulatory environment in Clinical Research
FDA – Code of Federal Regulations
FDA Audit procedures
Health Canada Clinical Trial Applications (CTA)
Health Canada inspections procedures
Health Canada Food & Drug regulations
• Understands the objectives of the clinical trials currently open to accrual and demonstrates knowledge of all active and inactive protocols at the Centre.
• The ability to read test results (i.e. pathology, radiology, cytology, biochemistry) and identify appropriate medical reports.
• Knowledge related to CRF, eCRF, PRO and ePRO, completion and ethics/regulatory submissions.
• Demonstrates ability to prioritize workload, with particular attention to detail.
• Proficient in MS Windows environment (Word, Excel, Power Point).
• Relevant clinical trials and/or oncology experience preferred.
• Working knowledge of computers and data entry experience.
• Demonstrates excellence in communication, both written and verbal
• Analysis / problem assessment
• Innovative and willing to learn
• Demonstrates individual leadership skills