Job Abstract

Reporting to the Senior Associate Vice President for Research Administration, the Director is responsible for the oversight and administration of Yale University’s comprehensive Human Research Protection Program (HRPP). Promotes the protection of human research participants through development and management of a program designed to foster a culture of respect for human research participants, including timely and thorough review of research protocols, meaningful education of the research community and proactive monitoring of the conduct of human research. Oversees development and implementation of policies, procedures, and programs for the effective and efficient administration of the HRPP in compliance with relevant federal regulations, state laws, sponsor requirements and University policies and procedures related to human research protection. Establishes and maintains standards of collaboration that is characterized by respect, professionalism and service.
The Director will serve as an important partner in the University’s desire to grow its clinical and translational research programs while meeting the goals of efficiency and effectiveness while maintaining practices and policies that assure continued compliance with FDA and OHRPP requirements.
Proven experience working with FDA auditors, Industry monitors, and FDA and OHRP regulations.
1. In collaboration with Yale's HRPP partners, establish processes to assure HRPP mission and goals are attained while facilitating a seamless approach to human subjects protection and research administration. 2. Serve as the Human Protection Administrator (HPA) for the University including serving as the lead contact for inquiries regarding audits and inquiries from Department of Health and Human Services, Food and Drug Administration, National Institute of Health and the Association for the Accreditation of Human Research Protection Programs. Ensure thorough and timely responses in collaboration with the University Research Compliance Officer and OGC. 3. Assess HRPP practices for alignment with federal and state regulation, local laws, accreditation standards and societal thinking related to approval, oversight and conduct of human research. Develop and oversee implementation and adherence to IRB and HRPP policies and procedures that meet industry best practice as appropriate to University culture. 4. Ensure that Assurances and Institutional Review Board (IRB) registrations are submitted appropriately. Evaluate external organizations or investigators for reliance upon the Yale IRBs to review human research projects and ensure that appropriate agreements are enacted and maintained in accordance with requirements. 5. Maintain responsibility for all business, process, performance, and problem solving activities undertaken by the HRPP components: the Institutional Review Boards (IRBs), Compliance Monitoring, and Education and Outreach. Help develop, review and adhere to the annual operating budget for all HRPP components. Oversee invoicing and collection of IRB review fees and procurement and payment of business expenses, travel, and other office needs. 6. Ensure efficient and compliant processes for review, approval and oversight of human research performed by the Institutional Review Boards (IRBs) designated by Yale on its Federal-wide Assurance. Provide consultation to the HRRP units; including the review of ethically and scientifically complex research, advising IRB members, Chairs and staff of review requirements based on policy, regulation, and relevant laws. Develop performance metrics to identify and implement efficiencies, evaluate 'value added' activities and decrease turnaround time of IRB handling processes. 7. Oversee the compliance program to ensure that human subject research is approved and conducted in accordance with appropriate federal and state regulations, guidance and institutional policy. Oversee the management of inquiries and responses regarding allegations of noncompliance by investigators and/or the IRB and reports of adverse events. Assist in identifying corrective actions to ensure the protection of human subjects and compliance with institutional policy. 8. Ensure the development and implementation of educational materials and activities for faculty, research staff, IRB members and staff and community research sites to foster compliance and facilitate understanding of human research rights and obligations. 9. Provide oversight and management of personnel and daily operations of the office including the hiring and performance management of staff. 10. Ensure that HRPP data management systems are effective and appropriately interfaced with other University systems and department applications. Develop and maintain administrative processes and systems that support the Yale's IRBs and research community. Ensure record keeping processes adhere to federal, state and local regulations and University policy. 11. Ensure the periodic performance review of the IRB membership and composition in order to maintain a diverse spectrum of qualified individuals. Assist in recruiting prospective IRB chairs and members and make recommendations to the University's Signatory Official and appropriate department chairs for appointments. Advanced degree in a relevant discipline and a minimum of seven years of experience in IRB-related activities.