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Quality and Education Specialist
1. Independently conducts risk based internal monitoring and quality control reviews for low to moderately complex YCC CTO supported studies. Works directly and in collaboration with YCC leadership, investigators, and research staff, to review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale Cancer Center and at affiliated Cancer Care Centers. 2. Evaluates the conduct of low to moderately complex clinical trials to ensure research integrity and compliance with institutional policies, state and federal regulations, and ICH Good Clinical Practice. 3. Creates and maintains quality management documentation related to processes and/or procedural deficiencies with CTO managed studies with limited supervision.
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