Director of the Office of Research Compliance

Monmouth University is seeking a knowledgeable, respected, goal-driven leader to join our team as Director of Research Compliance.  The successful candidate will have experience in compliance with federal and state regulatory requirements related to research activities. The Director provides direction and administrative oversight to all core components of the institution’s Human Research Protection Program (HRPP), the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), institutional biosafety, research misconduct, conflict of interests,  data privacy and security requirements, responsible conduct of research, research security and foreign influence, and export controls. The Director must have the ability to function independently in a team environment and serve as a lead for the research compliance programs associated with human subject and animal research. The Director oversees the IRB and IACUC Committees and supervises the IRB/IACUC Coordinator. The Director also serves as the University's Research Integrity Officer to oversee research misconduct. 

This is an in-person, on-campus, non-remote position.

Duties and Responsibilities:

• Plan, direct, and oversee research and compliance operations for the University, including, but not limited to the Institutional Review Board for Human Subjects (IRB), the Institutional Animal Care and Use Committee (IACUC), institutional biosafety, financial conflict of interest management (institutional, financial, and individual), data privacy and security requirements, responsible conduct of research, security and foreign influence, research misconduct, and export controls.
• • Direct and implement an internal quality improvement program. 
  • Develop and implement data privacy and research security requirements for all University research activities. 
  • Oversee Conflict of Interest management (institutional, financial, and individual) to ensure research compliance and compliance with applicable funded research.
• Work with appropriate internal resources to analyze data and prepare and present Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) audit reports and summaries, and provide feedback to the Institutional Official/Designee, researchers and the Institutional Review Board (IRB) as appropriate.
• • Act as a liaison with Federal and State agencies on human research issues as well as animal research issues.
  • Oversee compliance with export control laws and regulations and university policies and conduct regular audits to ensure compliance.

• Implement and oversee the necessary standards to maintain program accreditation.
  • Coordinate correspondence and responses for communications from the University's Senior Vice President/Provost for Academic Affairs/Institutional Official to external regulatory agencies

• Manage and oversee the Institutional Review Board (IRB) and the Institutional Animal Care and Use Program (IACUC).
• • Supervise the IRB/IACUC Coordinator.
  • Oversee and direct and guide the activities of the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) to ensure compliance with Federal and State regulations and University policies and procedures.
  • Design, develop, implement, evaluate, and modify technical and administrative Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) review processes and internal research auditing policies, protocols, systems, and procedures.
  • Work closely with Institutional leadership to ensure compliance with the ethical and regulatory requirements for human subject research as well as animal research.
  • Interact with Principal Investigators and other researchers involving IACUC and IRB policies and procedures. 
• Oversee research misconduct inquiries and investigations as the University's designated Research Integrity Officer (RIO).
• • Assist with specific inquiries related to scientific misconduct and/or research-related non-compliance issues, as necessary.
  • Create an environment that promotes responsible conduct and integrity in scientific research and develop and implement educational programs and workshops that enhance the responsible conduct of research. 
  • Manage highly sensitive and confidential research misconduct reports with recommendations for remediation, if applicable. 
  • Conduct training and educational sessions for PI's, faculty, staff and student researchers regularly concerning federal research regulations, conflicts of interest, foreign influence, data privacy and research security, human subject protections, animal care protections, export controls, and responsible conduct of research.
• Provide advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and University laws, regulations, and guidelines.
• Acts as liaison to the Office of Research and Sponsored Programs regarding grant congruency and all research compliance related questions and concerns. 
• Provide direction and integrative coordination in the planning, development and implementation of the Human Research Protection Program (HRPP).
• • Serve as principal point of collaboration, leadership and expertise to both internal constituencies and external constituencies on professional and operational matters pertaining to the Human Research Protection Program (HRPP).
  • Design, implement and evaluate organizational and staffing models to effectively accomplish the goals and objectives of the Human Research Protection Program (HRPP).
• Provide human subject protection expertise to IRB staff, the IRB Chair, and members as needed.
• Provide animal care and use expertise to IACUC staff, the IACUC Chair, and members as needed.
• • Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants as well as research involving animals and the University's Animal Care and Use Program.
  • Oversee IACUC compliance activities (e.g., IACUC semi-annual program reviews and facility site-inspections).
• Other duties as assigned.

Minimum Qualifications:

• Master's Degree from an accredited college or university.  
• Five (5) years of related experience working in a research compliance environment in higher education or a related field. 
• Knowledge of federal rules and regulations regarding human subject protections, animal care, and biosafety at a higher education setting or related field.
• Knowledge of regulations and ethical principles related to the ethical conduct of research, including responsible conduct of research and research misconduct regulations at a higher education setting or related field.
• Knowledge of research security program requirements, as well as data privacy and data management plans. 
• Ability to be highly detail oriented and meet strict deadlines.
• Ability to function independently in a team environment and serve as lead for research compliance programs across the University.
• Knowledge of export control laws and regulations and experience overseeing export control compliance.
• Intermediate knowledge of MS Word and Excel.
• Excellent interpersonal, organizational and communication skills.
• Must be able to treat confidential and sensitive information appropriately.

Preferred Qualifications:

• Demonstrated work experience with increasing responsibility both a human subject protection and animal care and use program.
• Experience supervising or conducting human subject research and animal research.
• Knowledge of Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and accreditation requirements,
• Health Insurance Portability and Accountability Act (HIPAA) regulations and state laws governing privacy, and Family Educational Rights and Privacy Act (FERPA) regulations.
• Experience conducting training or educational workshops in an academic setting.
• Prior managerial/supervisory experience.
• Experience working in a faculty union environment. 
• Certified IRB Professional (CIP) certification, Certified Professional in IACUC Administration (CPIA), or other appropriate certifications.
• Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards, as well as good clinical/research practices and standards.