Senior Research Compliance

4 days ago

Toronto Ontario, Canada St. Michael's Hospital - Unity Health Toronto Full time

Senior Research Ethics Compliance & Education SpecialistThe Unity Health Toronto Research Ethics Office (REO) and Research Ethics Board (REB) is currently seeking a Senior Research Ethics Compliance & Education Specialist.Under the direction of the Senior Director, Research Ethics, the Specialist will collaborate with researchers to facilitate clinical research studies, ensuring that all studies are conducted in accordance with Unity Health Toronto's policies, provincial and national policies, guidelines and regulatory requirements.In addition, the Specialist will work closely with the REB Chair, REB Vice-Chairs and Senior Director in the development of an overall education program for investigators and research staff; develop tools and templates to facilitate the efficient conduct of research; and conduct routine and "for cause" audits of research studies.The Specialist will be responsible for quality assurance, quality planning, control and improvement as it relates to the conduct of human research.Duties:Design and implementation of Unity Health's research quality and audit programConduct audits of approved human research studiesDevelop written standard operating procedures and study documentation that complies with scientific, ethical, regulatory, safety and institutional standards design and implement generic study management tools and templates for researchersPlan, implement and deliver education sessions related to research conduct and quality management Provide consultation and direction to the research community regarding the conduct of research and regulatory compliance for drug, biologic, natural health products and medical device trialsPerform cross functional and other duties as assigned and/or requested.Qualifications:Master's JOB TYPE Work Day:Full Time Employment type:Permanent Job Salary:Negotiable JOB REQUIREMENTS Minimal experience:Unspecified

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