Director of Institutional Ethics & Compliance

OFFICIAL JOB TITLE: Director of Institutional Ethics & Compliance

DIVISION: Academic Affairs

DEPARTMENT: Office of Research and Innovation

BARGAINING UNIT STATUS: Non-Unit

FLSA STATUS: Exempt

REPORTS TO: Chief Research Officer

SUPERVISES: May supervise student employees

SUMMARY PURPOSE OF POSITION:

This is an administrative position with decision-making responsibilities and leadership responsibility in directing, managing, and overseeing 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 incumbent directly supports faculty and students in research by serving as a subject matter expert on research ethics and compliance. The incumbent serves as a liaison between the Chief Research Officer and the campus committees required by regulation to provide oversight of research activities. The incumbent works closely with the Office of Research Administration, Research Development, Provost''''s Office, International Student Services Office, Department of Public Safety, Assistant Vice Chancellor for Environmental Health and Safety, Biosafety Officer, and Office of General Counsel to coordinate compliance efforts. The incumbent serves as the campus liaison for compliance issues to various federal and state agencies and departments. The incumbent 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 incumbent 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. Exceptionally high degrees of confidentiality and discretion are required in this position.

EXAMPLES OF PRIMARY DUTIES AND RESPONSIBILITIES:

• Evaluates compliance risks in higher education, research, and development; identifies and implements best practices.

• Interprets federal regulations and guidelines and develops, implements, reviews, and updates institutional policies to ensure research compliance with federal, state, and local regulations.

• Interprets and ensures institutional compliance with the following federal regulations and guidelines:

• 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), Foreign Assets Control Regulations, 31 CFR 500-599

• Serves as subject matter expert on research ethics and compliance matters; provides guidance and consultation to faculty, researchers, staff, and administrators on compliance and procedural issues.

• Keeps the Chief Research Officer informed of changes and emerging compliance issues that could impact research operations at the institution.

• Manages the Office of Institutional Ethics & Compliance. Serves on and provides administrative support to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and other compliance committees as needed. Ensures timely and appropriate follow-through on committee recommendations and regulatory requirements.

• Develops, implements, and administers comprehensive compliance training and education programs. Designs and delivers online and in-person outreach and training seminars on research ethics, compliance requirements, and regulatory obligations to faculty, students, and staff. Maintains documentation and records of training activities.

• Evaluates emerging compliance trends in higher education, research, and government; identifies and implements best practices. Networks with other university compliance officers to remain apprised of emerging compliance issues and share best practices. Participates in professional development activities and conferences to stay current with evolving federal, state, and local compliance requirements.

• Oversees export control and international compliance matters. Provides project management oversight for international sponsored projects. Maintains working relationships with key institutional partners including the Office of International Scholar and Student Services, International Programs Office, and other relevant departments. Reviews and maintains databases of international collaboration documentation (MOUs, Affiliation Agreements, Letters of Agreement). Works with appropriate offices to ensure international travel safety, country influence issues, and regulatory compliance for international activities. Collaborates on student and resident international travel documentation and risk assessments.

• Serves as campus liaison for compliance issues with various federal and state agencies and departments, including NIH, NSF, NSF, DOD, FDA, DEA, and others. Responds to agency inquiries and maintains compliance with external regulatory requirements.

• Responsible for effective staff management of the Office of Institutional Ethics & Compliance, including hiring, training and orientation, professional development, workflow and performance management, and promotion of an inclusive and innovative work environment.

• Develops contacts in federal, state, and private sector agencies. Maintains positive working relationships with faculty and staff at the University of Massachusetts Dartmouth as well as with colleagues at other University of Massachusetts campuses and in the broader research compliance community.

• Maintains high-quality management information systems, databases, and compliance documentation. Generates compliance reports as needed for internal stakeholders and external agencies.

MINIMUM QUALIFICATIONS:

• EDUCATION: Advanced degree (such as MS, MBA, JD) in business administration, public administration, law, or related field.
• EXPERIENCE: Over 5 years of extensive experience in research ethics and compliance, ensuring adherence to federal, state, local, and institutional regulations.
• Demonstrated expertise in export controls, conflict of interest (COI), research misconduct, human subjects, vertebrate animal research, biosafety, and the responsible conduct of research (RCR).
• Broad understanding of the compliance requirements of federal, state, and other regulatory agencies.
• 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.
• High level of competency with systems applications and databases.
• Excellent interpersonal and organizational development skills.
• 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.
• Interest in 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.

PREFERRED QUALIFICATIONS:

• Professional certification (such as Certified Research Administrator, Certified ITAR Professional, Certified U.S. Export Compliance Officer, or Certified Export Specialist).
• Experience in higher education, particularly in research compliance or research administration.
• Proven ability to form partnerships with faculty and staff to accomplish compliance objectives.
• Experience serving on or administering research oversight committees (IRB, IACUC, IBC, or similar).
• Experience with international research compliance and international scholar/student services.

SALARY: $145,000 -$170,000

UMass Dartmouth offers exciting benefits such as:

• 75% Employer-Paid Health Insurance
• Flexible Spending Accounts
• Life Insurance
• Long Term Disability
• State Pension Retirement Plan
• Optional Retirement Savings Plans
• Tuition Credit (Employee, Spouse, & Dependents)
• Twelve (12) paid holidays
• Paid personal, vacation, and sick time
• And More!

Benefits for Non-Unit Professional: Non-Unit Professional

Applicants must be authorized for permanent employment in the United States. Employment-based visa sponsorship is not available.

To apply, please submit a letter of interest, a current resume, and the contact information for three professional references.

The review of applications will be immediate and ongoing until the position is filled.