Regulatory Affairs Specialist - Bone Marrow Transplantation

Job description

JOB RESPONSIBILITIES: Protocol - Apply 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 by faculty and staff investigators. Work directly with individual faculty and staff investigators and research support staff to address human subjects issues during protocol review. Answer questions and problem solve for investigators, faculty, staff, research coordinators and students. Act as a liaison between IRB members and researchers to promote information flow. Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines. Under the guidance of senior staff, may assist in the development of protocol documents including...