DIRECTOR, RESEARCH COMPLIANCE

Overview

• The Director manages the campus' research administration compliance program and monitors compliance across a variety of research and non-research activities intersecting with the regulations. The Director provides leadership and support for analyzing and determining the applicability of regulatory schema to specific activities and recommends/implements strategies for ensuring compliance. The position is responsible for risk assessment and mitigation across a variety of research and campus activities. The incumbent works collaboratively with leadership in stakeholder units within and outside of the Office of Research as well as with oversight and implementation committees charged with responsibility for research compliance. 

• Reporting directly to the Associate Vice Provost, Research Operations and Compliance and working closely with the Office of General Counsel, the Director will design, , implement, and monitor an effective compliance program, which will include oversight of the University’s conflict of interest program for both institutional and research related conflicts, as well as the development of a research administration privacy program.

• In addition, the Director will serve as the University’s export control officer coordinating institutional-wide initiatives to prevent, detect and respond appropriately to federal regulations as they apply to the export control requirements (including federal embargoes and sanction programs), transfer of materials, and award terms and conditions. A critical component of the research compliance program is to work collaboratively with the Office of International Programs, Office of Technology Commercialization, Office of Environmental Health & Safety, Office of Audit, Compliance and Privacy, Office of the General Counsel, and the Office of Finance & Treasury.

Essential Functions:

Compliance Management within The Office of Research including:

• Oversee the operations of institutional compliance functions related to research administration, including, but not limited to: export control, conflict of interest, 340B, privacy and research integrity. Develop institutional policies, procedures, and performance metrics as they relate to research administration. The Director, Research Compliance effects the institutional research compliance program within the research administration. This is accomplished by administering and monitoring research the various compliance functions including but not limited to human and animal subjects, biosafety, export control, responsible conduct of research; and financial conflict of interest according to federal regulations. 

• Maintain institutional documentation and records related to compliance functions as they impact the research portfolio, and other essential regulatory matters. Ensure that research administration systems and processes capture sufficient data and support or complement the compliance program; participate in continuous improvement initiatives. Ensure the appropriate contractual documentation is executed prior to the transfer of confidential data, including the execution of Data Use and Business Associate Agreements. Ensure that the privacy rights of human research subjects are protected in accordance with federal and international privacy regulations and internal standard operating procedures.

• Establish, implement and maintain campus export control compliance policies, procedures and systems, including obtaining licenses. Evaluate potential export control risks and develop solutions to eliminate or minimize those risks. Monitor and provide analysis of export control regulatory developments that affect the University's export compliance efforts. Responsible for managing University compliance with federal export control regulations including the Department of Commerce Export Administration Regulations (EAR), the Department of State International Traffic in Arms Regulations (ITAR), Arms Export Control Act (AECA), Office of Foreign Asset Controls embargos (OFAC), Foreign Trade Regulations (FTR) and other applicable US export control regulations, including evaluating situations and making determinations regarding the interpretation and application of said export control regulations, and applying for licenses when necessary.

• Supervise the Compliance Analyst positions, assign tasks for the analysts to complete, review analysts’ work product and provide them with constructive criticism when necessary. Maintain proficiency and expertise in industry-standard regulatory and compliance matters. Design and head a Conflict of Interest Committee, for the purpose of reviewing and resolving complex conflict of interest disclosures.  Track, research and interpret proposed research related legislation and regulations for the purpose of keeping the University in compliance with state and federal law.  Implement and oversee employee and vendor sanction check procedures to maintain compliance with federal and state debarment and exclusion regulations, as they pertain to the disbursement of federal funds.

Internal and External Customer Service Including:

• Provide privacy guidance to University research staff regarding the utilization, transfer and maintenance of research subject personally identifiable information, as well as de-identified and aggregate data, in accordance with federal and international regulations including: HIPAA, HITECH, FERPA and GDPR. Develop research privacy policies and procedures and provide training to University staff, faculty, students to ensure proper understanding of any newly implemented or revised procedures. Serves as the campus contact for information and consultation on compliance requirements and best practices in research and sponsored programs, and provides training as appropriate for compliance and broader understanding of regulatory requirements.

• Act as the institutional point of contact for compliance matters, maintain confidentiality according to institutional guidelines, participate in and deliver, as appropriate, institutional professional development programs for faculty and administration. Interface extensively with pre-award and contracts within the Office of Research; interface extensively with the University Compliance Office and University Counsel. Communicate effectively and regularly with members of the University’s research community to effect job duties.

• Manage, develop and improve the University’s conflict of interest procedures. Ensure employee conflicts are properly disclosed by university staff, review conflict disclosures, provide guidance to University senior staff members pertaining the resolution of disclosed conflicts and develop conflict of interest management plans, as required. Work closely with the Executive Vice Provost for Research, Office of General Counsel, and Assistant Vice Provost, Research Operations and Compliance if a violation is discovered and self-disclosure and/or other action is necessary.

Other Duties as Assigned:

Perform additional duties and assist with special projects as assigned. Please note these percentages are subject to change at any time.

Required Education: Bachelor's Degree.

Required Experience: A minimum of 7 years.

Other Requirements:

• Possess excellent oral, written, listening, presentation, project management, and interpersonal skills. Possess subject matter expertise including advanced knowledge of applicable federal, international and state regulations (e.g. OMB A-21, A-110, A-133, HIPAA, FERPA, GDPR and FAR), funding source requirements (e.g. NIH, NSF, and NEH); accounting and auditing standards and familiarity with general accepted accounting principles.

• Experience with export control analysis, education, licensing or compliance either at a US university, federal government agency, or defense, engineering or life sciences industry. In-depth knowledge of Export Control Regulations (Export Administration Regulations, International Traffic in Arms Regulations and Office of Foreign Assets Control Regulations) and licensing requirements. Detailed knowledge of export control regulations as they apply in an academic environment.

• Must possess general knowledge of the types or regulations governing international research collaborations, both within and outside the area of export control. Demonstrated ability to develop independent recommendations for action as it relates to complex and varying individual export control situations, including identifying the applicable regulations, exemptions and exclusions for a given situation.

• Thorough understanding of intellectual property issues as they relate to ownership, licensing, patenting and transfer of materials and knowledge in US and abroad. Demonstrated ability to design, develop, deliver and assess training. Ability to use the basic concepts and practices employed in training large and small groups of professional adults. Ability to collaborate effectively with colleagues and professionals from other entities.

Preferred Qualifications:

• Master’s Degree or JD in related field preferred.
• In-depth expertise in export controlled research preferred.
• Familiarity with the operating implications of federal requirements related to conflict of interest, export controls, sub recipient monitoring, and other research compliance matters preferred
• Advanced knowledge of privacy regulations, specifically as they relate to human subject research compliance.
• Demonstrated understanding of complex conflict of interest issues, and the ability to investigate, review and resolve employee discolsed conflicts.