Director of Research Compliance

Office for Research Duties And Responsibilities: The Director of Research Compliance reports to the Dean of the Faculty of Medicine through the Dean for Faculty and Research Integrity. The Director is responsible for the coordination, management, monitoring and communication of the Medical School's research compliance programs, including regulatory and compliance matters in the areas of grants management, intellectual property, export controls, post 9-11 regulations, human and animal subjects research, biological safety, conflict of interest, faculty consulting and other external activities, scientific misconduct, data sharing and data retention, data and information confidentiality and security, and human Embryonic Stem Cells, as examples. The Director will work closely with numerous University and Medical School departments and offices including OSP, SPA, FOA, OTD, ORSP, OFA, ORI, OGC, HR, Ombuds, OPA, GCPA, RMAS, ORM, and other regulatory affairs and research compliance functions, and with Medical School faculty and administrators, in carrying out the responsiblilies of the office. The Director will also coordinate activities with senior research administrators, policymakers and compliance officals in other tubs, particularly in FAS and SPH. The compliance related duties and responsibilities of the position include identifying areas of research risk and developing strategies to address identified research compliance issues; leading or assisting in the conduct of non-compliance investigations and the appropriate reporting of confirmed instances of noncompliance to internal officals and external agencies; coordinating or assisting with inquiries and investigations relating to allegations of scientific misconduct; coordinating and providing training and education to investigators and staff in areas of research compliance; monitoring federal, state and local research compliance laws and regulations; assisting in the development and maintenance of polices and procedures to comply with such requirements; leading or assiting in the development of improved internal controls, oversight systems or business processes designed to enhance compliance; providing guidance and support to offices responsible for research-related compliance functions; assisting in research-related accreditation processes; serving as a consultant and resource to members of the HMS community on research compliance issues; developing and implementing a quality assurance program; serving as liaison to outside regulatory agencies on research compliance issues; disseminating information about research compliance to the HMS research community; receiving and coordinating responses to individual complaints; maintaining the ORC confidential research complaint telephone line; keeping records and documenting training, complaints, and research compliance activiites. Basic Qualifications: The successful candidate should have an advanced degree in biomedical sciences, finance or business, law or public policy and should have five to seven years experience in a complex research and/or regulatory environment. Additional Qualifications: The sucessful candidate should have excellent interpersonal skills and demonstrated ability to deal effectively and confidentially with difficult situations and with individuals at all levels (faculty, staff, deans, etc.) ; experience working in a matrix organization; and demonstrated ability to relate to multiple areas and constituencies while maintaining a wider organizational view. The successful candidate must be self-motivated and able to work independently. The successful candidate must have strong verbal and written skills and must be proficient in computer applications. Additional Information: The regulatory affairs related responsibilities of the position include: participating on governmental affairs related activities; participating with the development of strategies for interaction, communication and advocacy with government officials and agencies; participating in the preparation of public comments or position papers on proposed legislation and regulations, preparing backround memos or talking points on various regulatory issues; serving on university research policy development committees; participating in the responses to requests for data, information or documents under freedom of information or similar laws; reviewing and approving faculty consulting agreements; and advising faculty on regulatory and institutional policy compliance issues related to their internal and external activities. The Director is responsible for managing the Office for Research Compliance and supervising a Staff Assistant III. Click Here to Apply