The Compliance Specialist of the Institutional Review Board (IRB) reports to the leadership of the Human Subjects Protection Office. The individual serving in this role will be a team lead and perform regulatory review within the Penn State College of Medicine Human Subjects Protection Office and the IRB. This individual will work with the guidance of the Director/leadership of the Human Subjects Protection Office. The IRB Compliance Specialist will join a team of other professionals who are responsible for conducting pre-reviews and reviews of submissions to the Penn State College of Medicine IRB, including new protocols, continuing reviews, modifications and reportable new information for compliance with federal and state regulations and institutional policies. This staff member will initiate written correspondence with the investigators, requesting clarification and/or additional information when needed. In addition, the individual will assist faculty, students and staff in preparing human research protocols for compliance, serving as a subject matter expert by providing guidance and training to researchers, faculty, staff, students and IRB members. The selected candidate will interact with various compliance committees as needed, manage the appropriate documentation related to the compliance review and approval, assist in developing policies and procedures to ensure compliance with governmental regulations, and may assist in hiring, supervising, training and/or evaluating assigned staff. Typically requires a Bachelor's degree or higher plus six years of related experience, or an equivalent combination of education and experience. Excellent organizational, verbal and written skills are required. Individuals with a degree in nursing or extensive clinical research coordination background highly preferred. CIP (Certified IRB Professional) credential required within one year of eligibility.
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