Director of Research Compliance

Responsibilities

• Serve as the institutional authority on research compliance matters related to human subjects research, animal welfare and use in research, and rsDNA/biological hazards research, providing final determinations on compliance-related issues
• Contribute to the research compliance program quality assurance program, overseeing and managing IRB, IACUC, and IBC continuous improvement activities, training, and incident/issue reporting and resolution; conducting regulatory compliance reviews related to IACUC and IBC protocols
• Oversee IRB, IACUC, and IBC research electronic compliance systems to ensure effective data management, record retention, and reporting
• Provide strategic oversight of IRB, IACUC, and IBC operations, ensuring appropriate review and monitoring procedures are in place and intervening in complex or high-risk protocols; developing and implementing policies and procedures
• Monitor and interpret regulatory research compliance statutes, laws, and regulations related to human subjects research, animal welfare and use in research, and rsDNA/biological hazards research; evaluating risk and developing risk mitigation strategies related to IRB, IACUC, and IBC operations
• Perform other duties as assigned

ORC Management and Strategic Initiatives

• Provide consultation to internal and external stakeholders in matters and areas related to regulatory research compliance, serving as a subject matter expert in human subjects research protections, animal welfare and research, and rsDNA/biological hazard use
• Lead and collaborate with Division of University Research (DUR) offices, central administrative units, and colleges and schools in the implementation of research compliance policies and procedures required by U.S. federal and NJ state research laws, statutes, and regulations
• Participate as a member on university committees, representing the Office of Research Compliance, as needed

Leadership and Institutional Support

• Promote a culture of ethical research and compliance across the institution through leadership, education, and engagement
• Respond to external entities and governmental departments and offices conducting investigations, audits, or other reviews; includes liaison with external entities, identification and collection of data, materials, and documents, drafting responses, and implementation of resolution plans

Education And Experience

• Masters Degree
• 7 years of experience related to research regulatory administration
• Juris Doctor or Masters of Law
• 10 years of experience related to research regulatory administration
• Certified Professional in IACUC Administration (CPIA)
• Certified IRB Professional (CIB)

Skills And Knowledge

• Knowledgeable in U.S. federal research regulatory laws, statutes, and regulations
• 45 CFR Part 46, Protection of Human Subjects
• 21 CFR Parts 50, 56, and 81
• PHS Policy on Humane Care and Use of Laboratory Animals
• Health Research Extension Act of 1985
• Animal Welfare Act and Regulations
• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Knowledgeable in U.S. higher education administration
• Able to read critically and interpret laws, statutes, and regulations; developing institutional policies and procedures
• High level of organization and analytical skills
• Excellent verbal and written communication skills
• Able to identify problems and develop solutions