Director, Research Compliance

. Director of Research Compliance JOB DESCRIPTION The Director of Research Compliance implements, directs, and leads the research compliance program related to all research including clinical, translational, and other research. The Director will be responsible for the creation of the Office of Research Compliance. This position provides leadership and guidance in all aspects of the research compliance program, including responsibility for investigation and resolution of research compliance issues; conducting a research compliance risk assessment; maintenance of research compliance policies and procedures; providing regulatory guidance and advice on research compliance matters; and conducting or coordinating focused training and education on research compliance. Minimum 5 years of experience in the research compliance field required; 7+ years preferred.

• Essential Functions

• Coordinates and supports existing research compliance activities across hospital regarding

• federal and state laws and regulations, accreditation and certification requirements, and other

• applicable standards.

• Achieves research compliance objectives by working with a variety of departments and offices, including Research Administration, Research Finance, Research

• Operations, Office of Sponsored Programs ("OSP"), Institutional Review Board ("IRB"),

• Institutional Animal Care and Use Committee ("IACUC"), Institutional Biosafety Committee ("IBC"), Quality Assurance and Education ("QA"), Billing Compliance, Privacy, and Financial Conflicts of Interest ("FCOI").

• Works well and coordinates with counterparts at other institutions and outside research sites.

• Develops, implements, maintains, and oversees policies and procedures regarding compliance

• with federal and state laws and regulations associated with external funding of research activities

• including effort reporting, allowable cost principles, subrecipient monitoring, and other requirements for recipients of federal and nonfederal funding.

• Develops, implements, and directs the export compliance program for to ensure compliance with export control laws and regulations, including the International Traffic in Arms Regulations ("ITAR"), the Export Administration Regulations ("EAR"), and the regulations administered by the Treasury Department's Office of Foreign Assets Control ("OFAC").

• Develops, implements, maintains, and oversees training and education program for research

• compliance issues, including, for example, new hire orientation, annual mandatory research compliance training and department-specific training.

• Develops annual work plan to address identified risks, including conducting risk assessment, audit and
• monitoring activities. Oversees external entities retained for reviews. May review all documents and other information relevant to research activities.

• Conducts inquiries and investigations relating to allegations of research misconduct and works with the Committee for Research Integrity ("CRI"). Receives, investigates, documents, and tracks research compliance complaints from workforce members, patients and/or family members, the Compliance Helpline, or other sources. Develops and implements (or oversees implementation of) corrective action plans (including ensuring consistent application of disciplinary action standards) in response to such complaints and investigations.

• Serves as a resource on the laws, regulations, and internal policies related to research including

• U.S. Department of Health and Human Services, U.S. Department of Agriculture, and Food and Drug Administration ("FDA") regulations. This includes the use and disclosure of protected health Information ("PHI") for research purposes in coordination with the Chief Privacy Officer.

• Provides guidance on federal and state laws and regulations, as well as commercial insurance policies, regarding the billing and payment for services rendered to human subjects on clinical trials.

• Stays current with relevant federal and state research compliance laws and regulations and
• modifies the research compliance program accordingly to remain compliant, as well as consistent
• with industry best practices; cooperates with federal and state entities in any research compliance program audits, inquiries, or investigations.

• Requirements

• Bachelor's Degree required. Master's Degree (and areas of study should include health policy, research administration, business administration or legal/regulatory) preferred. Post Graduate Juris Doctorate degree preferred.

• Must have valid compliance certifications: Certified in Healthcare Compliance (CHC) and Certified in Healthcare Research Compliance (CHRC)

• Certified in Healthcare Privacy Compliance (CHPC) preferred

• Minimum 5 years of experience in the research compliance field required; 7+ years preferred.