Dir., Reg. Compliance for Laboratory Programs

About The Unit: The University of Chicago established the Office of Research Safety to pair rigorous inquiry with safe laboratory practices. Three hazards commonly found in research labs are biological, chemical, and radiological. Our programs are designed to address these hazards by providing up-to-date information, training, and consultation delivered by our experienced teams. The University of Chicago and Office of Research Safety ensures that safety of all laboratory personnel, non-laboratory personnel, and the environment remains a top priority. Our mission is to partner with researchers across campus to ensure that laboratory research is conducted safely and according to federal and institutional guidelines. It is our belief that research safety is essential to the responsible conduct of scientific inquiry. Our mission is to partner with researchers across campus to ensure that laboratory research is conducted safely and according to federal and institutional guidelines. It is our belief that research safety is essential to the responsible conduct of scientific inquiry.

Unit Job Summary: The Director of Regulatory Compliance (DRC) reports to the Associate Vice-President for Research Safety (AVP ORS) and is responsible for ensuring the University of Chicago's compliance with international, federal, state, and local rules, regulations, guidelines and ethical principles regarding aspects of life-sciences research. This includes responsibility for governing compliance for research activities involving the use of animals and/or potentially hazardous substances including recombinant or synthetic nucleic acids, infectious agents (pathogenic microorganisms and/or infectious proteins), and in vivo use of chemical reagents and/or biological toxins. Oversight: Provide oversight for the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), the Select Agent Biosafety Committee (SA IBC), and post-approval monitoring of research activities; serve as a lead institutional representative during on-site audits of the laboratory research program, including USDA inspections, CDC Select Agent Program inspections, AAALAC site visits, OLAW inspections and sponsor-associated site visits. Will work with University Research Administration on grants and contract issues related to laboratory research such as Memorandums of Understanding and Material Transfer Agreements. Training, Communication and Service: Assure compliance with training programs for each regulatory area under their domain. This includes specialized training for committee members (faculty, staff and community members) as well as content specific training for research community (faculty, staff, students and post-doctoral fellows). Development and maintenance of policy and procedure manuals, websites and standard operating procedures (SOPs) for each committee and program area for which oversight is provided. Assurances, Accreditation, Certifications, Registrations: develop and maintain protocol management systems (databases), regulatory documentation and operational metrics to ensure that information being collected for the regulatory committees are audit-ready, used in managing the respective regulatory areas and meet federally-mandated record keeping requirements. Committee Operations: supervise the research protocol and protocol amendment review process, including preparations for the monthly IACUC, IBC and SA IBC meetings and communicating the resulting protocol review outcomes to the PIs and others potentially involved with the protocol.

Unit Education: Bachelor's Degree in biological sciences required; Master's or advance degree highly preferred; CPIA (Certified Professional IACUC Administrator) certification preferred

Unit Experience: Five or more years of administrative experience with direct and obvious relevance to regulatory compliance and research with animals and biohazards required. In depth knowledge of relevant federal, state or local regulations, knowledge of laboratory research and familiarity with laboratory research technology required. Five or more years supervisory responsibility preferred.

Unit Job Function Competencies: Strategic leadership skills required. Supervisory skills required. Budget management skills required. Project management skills required. Significant knowledge of relevant federal, state and local compliance laws and regulations required. Analytical skills required. Problem-solving skills required. Decision-making skills required. Attention to detail required. Organizational skills required. Verbal and written communication skills required. Interpersonal skills required. Ability to work independently with a high degree of initiative required. Ability to work as part of a team required. Ability to maintain confidentiality required. Proficiency in Word and Excel required. Ability to manage stressful situations required. Knowledge of database management software required.