Assistant Director Compliance And Quality

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Assistant Director, Compliance and Quality
Duties: Reporting to the Director, Human Research Protection Program, the Assistant Director, Regulatory, Compliance, and Quality is responsible for applying applicable laws, regulations, local requirements, guidelines, accreditation standards, and policies to support Yale’s Human Research Protection Program (HRPP), including the facilitation of compliance and quality assurance activities and assistance with operational initiatives necessary to support HRPP efforts. Regulatory Monitor changes in applicable laws, regulations, local requirements, guidelines, accreditation standards, and policies in order to assess the impact on human subjects research oversight, HRPP operations, and the business processes that support these efforts. Provide advice and serve as a resource to the University community, including investigators, research staff, applicable committees (e. g. , IRB, RDRC, etc. ), regarding human subjects related matters and requirements set forth in pertinent authorities, including HRPP and committee policies and practices. Review and collaborate with the HRPP Director regarding University policies, standard operating procedures, work instructions, guidance documents, checklists, forms, and other documents to ensure compliance with applicable regulatory and university requirements. In collaboration with HRPP management, provide advice regarding IRB reliance and related reliance agreements. Advise the Yale IRBs and HRPP staff regarding applicable regulatory and institutional requirements related to human subject protection matters and ensure that all required regulatory actions are taken by the Yale IRBs in their review of the research studies. Compliance and Quality Assurance In collaboration with the HRPP Director, lead human subjects research oversight activities by assisting and/or conducting internal and external reviews, audits, and inspections, including working with the HRPP Director, Office of the University Provost, Office of General Counsel, and other designated University entities in investigating and responding to internal and external reviews, audits, and inspections. Manage the systematic reviews that evaluate researchers’ and their study team’s compliance with IRB approved protocols and applicable laws, regulations, guidelines, accreditation standards, local requirements, and policies and ensure that recommended corrective and preventative actions are appropriate. Lead the HRPP compliance quality monitoring program, including the monitoring of internal and external IRB compliance. Provide oversight regarding compliance issues and complaints, and appropriately escalate such items when necessary to the HRPP Director, University Research Compliance Officer, and other University entities for investigation and resolution. In collaboration with the HRPP Director, develop and implement a post-IRB approval program of research studies involving human subjects as required under the Association of Accreditation of Human Research Protection Programs (AAHRPP), University-wide Compliance Program, as well as other quality improvement activities across Yale University. Ensure that required reporting is tracked and current, including reports on audit and monitoring findings and reports requested from sponsors, federal agencies, and other oversight bodies. Manage the HRPP Compliance and Quality Assurance Manager and Specialists in the handling of compliance issues and complaints, including the appropriate escalation to the HRPP Director and other Yale offices for investigation and resolution. Ensure that periodic audits of external IRBs with studies under their oversight are conducted in order to ensure compliance with all applicable laws, regulations, guidance, University policies, and contractual requirements.

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