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Specialist -Regulatory Affairs - Bone Marrow Transplant
DescriptionSUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks.REPRESENTATIVE RESPONSIBILITIES???ProtocolApply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations.Oversee the review and correspondence of research protocols.Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations
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