Title: Director of Institutional Ethics & Compliance
Division: Provost / Academic Affairs Division
Status: Non-Unit Professional Exempt
EEO Status: 3.1
Job Code: 056
Reports To: Chief Research Officer
Supervises: Director of EH&S, may supervise student eemployees.
Summary Purpose of Position: The Director of Institutional Ethics & Compliance directs, manages, and oversees compliance with federally mandated regulations, in addition to state, local, and institutional policies that involve research, including: export controls, conflict of interest, research misconduct, human participants, vertebrates, biosafety, and responsible conduct of research. The Director directly supports faculty and students in research by serving as a subject matter expert on research ethics and compliance. The Director serves as a liaison between the Chief Research Officer and the campus committees required by regulation to provide oversight of research activities. The director works closely with the Office of Research Administration, Research Development, Provosts Office, International Student Services Office, Department of Public Safety, Director of Environmental Health and Safety, Biosafety Officer, and Office of General Counsel to coordinate compliance efforts. The Director serves as the campus liaison for compliance issues to the various federal and state agencies and departments. The Director manages the Office of Institutional Ethics & Compliance and serves on and is administrator to the IRB, IACUC, IBC and other compliance committees as needed. The Director teaches and educates through online and in-person outreach and training seminars on relevant topics in research ethics and compliance to faculty, students, and staff.
Examples of Duties and Responsibilities:
- Evaluate compliance risks in higher education, research, and development; identifies and implements best practices.
- Interpret federal regulations and guidelines and develop/implement/review/update institutional policies to ensure research compliance with:
- Animal Welfare Act and USDA regulations related to animal care and use;
- Office for Human Research Protections, Protection of Human Subjects, 45 CFR 46;
- Food and Drug Administration, Protection of Human Subjects 21 CFR 50;
- National Institute of Health, Office of Biotechnology Activities Guidelines for Research Involving Recombinant DNA molecules;
- Drug Enforcement Agency Controlled Substances Regulations 21 U.S.C. §800 - 971
- Department of Commerce, BIS, Export Administration Regulations (EAR) 15 CFR 730 – 744;
- Department of State, 22 U.S.C. 2778 of the Arms Export Control Act: International Traffic Arms Regulations (ITAR) 22 CFR 120-130;
- Department of Treasury, Office of Foreign Assets Control (OFAC);
- Export Control and International Compliance – Evaluate emerging compliance trends in higher education, research, and government; identifies and implements best practices; network with other university compliance officers to keep apprised of emerging compliance issues, share best practices, etc. Provide project management oversight for international sponsored projects. Assure timely and appropriate follow-through; Maintain working relationships with key institutional partners (Office of International Scholar and Student Services, International Programs Office) as it relates to international activities and operations; Review and maintain database of international collaboration documentation (MOU’s, Affiliation Agreements, Letters of Agreement) related to educational, research and service activities for the Office of Scholar and Student Services; Work with the Office of Scholar and Student Services and International Programs Office to ensure any international travel safety and/or country influence issues are addressed; Collaborate on student/resident international travel, ensuring appropriate documentation and risk assessments are completed; Work closely with the Office of International Programs Office to ensure compliance processes for international travel, visiting scholars and student exchanges.
- Conflict of Interest Committee - Evaluate COI disclosures; work with Chief Research Officer on appropriate oversight. Work with faculty, chairs and deans on implementing effective COI disclosure program as it relates to research related activities.
- Outside Activities (OA) Committee – Evaluate OA disclosures and work with the Chief Research Officer on appropriate oversight. Work with faculty, chairs and deans on implementing effective OA disclosure program as it relates to research related activities.
- Review and approve material transfer agreements, confidential/non-disclosure agreements, and other agreements - as well as solicitations and sponsored research agreements - for export control implications; accept or revise language addressing export control in agreements; participate in negotiations (with other stakeholder units) as may be necessary to resolve export control concerns.
- Serve as first point of contact for enforcement agency outreach.
- Develop and deliver a comprehensive training and outreach program for senior management, faculty, researchers, staff, and students with the aim of fostering a “culture of compliance” for research and related activities and to ensure that all affected employees understand and comply with pertinent federal and state standards; promotes compliance awareness across campus.
- Review and respond to reports of non-compliance; investigate and/or coordinate with other internal/external investigations into matters related to non-compliance; formulate campus responses to external reviews and findings; recommend and ensure an appropriate corrective action plan; coordinate any necessary self-disclosure of violations in cooperation with the General Counsel and others as needed.
- Represents the University as liaison to OLAW, OHRP, and other regulatory agencies.
- Produce and submit annual and semi-annual reports;
- Update and revise assurances;
- Serve as liaison during audits by federal agencies;
- Review correspondence with federal agencies;
- Oversight of and responsibility for the Office of Institutional Ethics & Compliance and university research.
- Participate and serve on all research oversight committees (IRB, IACUC, IBC);
- Review all IRB, IACUC, and IBC protocols;
- Schedule committee meetings, manage agenda and minutes, draft committee correspondence;
- Coordinate with ORA to assist with monitoring of pre- and post-award compliance for external and internal projects;
- Oversee development and implementation of compliance website database for all IACUC, IRB, and IBC researchers;
- Maintain and manage compliance files and records.
- Execute proactive programs to ensure compliance.
- Provide guidance and advice on regulations, compliance and ethics to PIs, researchers, students, staff, and administration;
- Partner with CVIP, ORA, EHS, Public Safety, and Provost’s office to support institutional compliance and research;
- Collaborate with Enterprise Risk Management to conduct risk assessments, mitigate international travel risks, and identify foreign influence concerns.
- Collaborate with the International Scholar and Student Services Office to implement procedures and processes for international travel, visiting scholars and student exchanges that promote compliance.
- Analyze campus activities for compliance with export control regulations and oversees the development and implementation of technology control plans; develop and submit license applications for export to the State Department, the Commerce Department through the Bureau of Industry and Security, and the Treasury Department through the Office of Foreign Asset Control. Conduct internal audits of export control documents, processes and procedures; investigate suspected export violations as required; collaborate with university legal counsel or outside expert counsel in the preparation of Voluntary Disclosures where violations are identified.
- Monitor compliance and assess the adequacy of compliance activities and programs throughout the research area and in other related campus activities; periodically revise the compliance program to respond to changes in regulatory or policy environments.
C. MINIMUM QUALIFICATIONS: (Minimum required level of education; required licenses; years and nature of related experience; unique requirements related to physical ability, travel, working evenings and weekends, etc.)
- Master’s degree in business administration, public administration, law, or related field.
- More than six years of experience in higher education, preferably in a leadership role in research compliance or research administration.
- Broad understanding of the compliance requirements of federal, state, and other regulatory agencies.
- High level of competency with systems applications and databases.
- Excellent interpersonal and organizational development skills.
- Proven leadership and supervisory skills and experience.
- Well-developed analytical and problem-solving skills; ability to innovate.
- Excellent communications skills and the ability to effectively communicate with people at all levels of the organization. Ability to be flexible, tactful, and diplomatic.
- High degree of personal integrity and ethics with uncompromising standards.
- Proven ability to form partnerships with faculty and staff to accomplish compliance objectives.
- Experience developing and delivering training or education workshops in an academic setting.
- A commitment to professional development and the ability to travel to national and regional meetings for training, updates, networking, and making presentations.
- Professional certification (e.g., Certified Research Administrator, Certified ITAR Professional, Certified U.S. Export Compliance Officer, Certified Export Specialist) is preferred.
- In depth knowledge of U.S. regulations governing export control, trade compliance or sanctions and embargoes, preferably with specific emphasis on how these impact research-intensive organizations.
- This position will have access to export controlled technologies, therefore candidates for this position must be U.S. persons.
Applicants must be authorized for employment in the U.S. on a full time basis. Employment-based visa sponsorship not available.
Effective September 27, 2021, UMass Dartmouth requires that all members of the campus community are fully vaccinated against Covid-19 and provide proof of vaccination.
To apply please submit a letter of interest, current resume and the contact information for three professional reference.
The review of applications will begin October 14, 2021.