The Associate Director of IACUC, IBC, and PAM is a highly responsible position, which involves the management and oversight of the daily activities of the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC), and the Post-Approval Monitoring Program (PAM). This role interprets federal regulations and policy; develops University policies, guidelines, and procedures relative to that interpretation; administers the committees and interacts directly with federal, state, local and other agencies when they come to inspect/audit or visit Princeton University. This positions interacts 1-on-1 with researchers, administrative staff, committee members, and students to facilitate approval of research proposals in compliance with all regulations. This role oversees the development of educational programs and the training of the committee members, faculty, researchers, staff and students. This role will have primary oversight of the AAALAC site visit preparation, OLAW assurance renewal, USDA inspections, and submission of annual reports to all regulatory agencies. They will oversee the adverse event reporting process and help to develop appropriate corrective action plans. This individual will be the primary liaison facilitating collaborative discussions between the RIA office and the LAR and NRP veterinarians, IACUC and IBC Chairs, BSO, PI labs, and research support staff. This position requires time-sensitive, rigorous performance and deliverable deadlines and may require an irregular work schedule / evening / weekend / extended work hours. This position has four direct reports.
Responsibilities
Oversee and administer the Institutional Animal Care and Use Committee (IACUC): -Monthly IACUC meetings (~12 per year) plus ad hoc meetings as needed to discuss special topics. -Provide support to the IACUC committee and animal research community on eRIA IACUC electronic protocol management system. -Provide training to animal research community as required by regulations. -Assists researchers to write and amend animal protocols as needed. -Voting member of IACUC. -Review all animal use protocols under consideration by the IACUC to identify any issues related to compliance with federal and state policies and regulations. -Collaboratively lead and manage inspections and site visits from regulatory agencies.
-Primary contact for regulatory inspectors/auditors/site visitors for USDA, OLAW, AAALAC, and New Jersey Fish and Wildlife. Prepares and submits all regulatory documents and annual reports for USDA, OLAW, AAALAC, and New Jersey Fish and Wildlife. -Leader in the writing of the AAALAC program description in conjunction with LAR, NRP, and EH&S. -Leader in Writing OLAW Assurance. -Responsible for accurately organizing and compiling required data and documentations for oversight and accreditation agencies. -Oversees semi-annual facility inspection and program review. -Oversees Adverse Event reporting process. Organizes subcommittee meetings and helps to develop appropriate corrective action plans. -Create special reports in response to committee requests, policies and position statements, and metrics as directed by Director of RIA or the Dean for Research. -Provide orientation of new IACUC Committee members with regard to expectations and responsibilities; including but not limited to, the animal proposal review process, semi-annual program review, and facility inspections. -Works with the RIA Director, IACUC Chair and AV to implement any policy changes or new procedures involving animal care and use. -Assists in developing correspondence, editing and disseminating new information regarding animal research procedures. -Provide information to the committee regarding current USDA regulations and PHS policies. -Direct daily operations; including supervision, performance evaluation, and mentoring of IACUC and PAM coordinators. -Works with departments to identify new committee members. -Serve as a principal point of contact for information regarding research compliance, provide expert knowledge of regulations governing animal research, and apply this knowledge to ensure the organization is in excellent standing and develops and implements strategies to maintain this excellence.
Oversee and administer the Institutional Biosafety Committee (IBC): -Bi-monthly IBC meetings (~6 per year) plus ad hoc meetings as needed to discuss special topics. -Provide support to IBC committee and animal research community in eRIA IACUC electronic protocol management system. -Provide training to the animal research community using biohazardous agents as required by regulation. -Assists researchers to write and amend biohazardous registration documents as needed. -Works with the RIA Director, IBC Chair, BSO and AV to implement any policy changes or new procedures involving biohazards. -Reads all IBC registrations under consideration by the IBC. -Ensure congruency between IACUC protocols and IBC registrations. -Works with Biosafety Officer to prepares and submit regulatory documents for OSHA and AAALAC. -Primary contact for regulatory inspectors/auditors/site visitors for Office of Biotechnology Administration (OBA) and AAALAC. -Assists in developing correspondence, editing and disseminating new information regarding biohazards. -Provide information to the committee regarding current regulations and CDC guidelines. -Work collaboratively with BSO. -Direct daily operations; including supervision, performance evaluation, and mentoring of IBC and PAM coordinators. -Works with departments to identify new committee members. -Serve as a principal point of contact for information regarding research compliance, provide expert knowledge of regulations governing the use of biohazards, and apply this knowledge to ensure the organization is in excellent standing and develops and implements strategies to maintain this excellence.
Oversight of post-approval monitoring (PAM) program that reaches across multiple University functions (IACUC, IBC, IRB, EHS, and Occupational Health) and academic departments:
-This program serves to ensure compliance with approved protocols and registrations. The PAM program works one-on-one with faculty, PIs, research support staff, and students to facilitate compliant research in a collaborative and supportive manner. The PAM program helps to self-identify potential compliance issues and provide training and corrective action plans as needed. PAM follows-up on adverse event reporting and performs lab audits as requested. -Direct daily operations; including supervision, performance evaluation, and mentoring of PAM coordinators.
Serve as subject matter expert in developing workflow maps and processes, training materials, and needed upgrades for eRIA IACUC and eRIA IBC electronic management systems: Working with various IT groups, project managers, systems analysts, to develop training materials and deliver them to researchers and committee members. Oversee testing associated with new or proposed changes. provide input on important reports to be generated and participation in data warehouse project. Participate in meetings when needed to discuss electronic management systems in other departments (LAR, EH&S, UHS) that directly interact with eRIA.
Qualifications
CERTIFICATIONS REQUIRED: PRIM&R Certified Professional Institutional Animal Care and Use Committee (IACUC) Administrator (CPIA)
Essential Qualifications:
-More than 10 years of related IACUC and IBC committee oversight experience required. -Extensive knowledge of the academic research environment from having worked in academia and having served as an advisor to leadership. -Knowledge of documentation, regulations, and processes to maintain complaint animal, recombinant material, and hazardous substances research. -Knowledge of USDA, AAALAC, OLAW, OBA regulations and guidance. -Experience with AAALAC site visits and accreditation, OLAW Assurance and United States Department of Agriculture (USDA) inspections. -Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented -Demonstrated ability, using critical thinking skills, to effectively lead, manage, supervise, and strategically plan administrative operations. -Minimum of 5 years people management experience. Advanced management/leadership experience in a multi-programmatic and multidisciplinary academic work environment. -Demonstrated leadership skills to direct and motivate staff. -Demonstrated ability to effectively administer and manage complex department operations and programs based on analysis, judgment and knowledge of applicable federal, state, and institutional policies and regulations in an academic environment. -Must possess excellent interpersonal and diplomacy skills, and the ability to build collaborative relationships at all levels with proven ability to exhibit tact and diplomacy in sensitive situations. -Exercises sound judgment and discretion in matters of significance -Must have innovative problem solving and troubleshooting skills with ability to make sound recommendations. -Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills. -Excellent oral and written communication skills. Ability to compose reports, correspondence, and summaries in a comprehensive and organized manner.
Preferred Qualifications:
-Masters of Laboratory Animal Science (MLAS) or CMAR/LATG certification from the American Association of Laboratory Animal Science (AALAS) preferred. -Familiarity with electronic protocol review/management systems is strongly preferred. -Previous oversight of post-approval monitoring program is strongly preferred. -Experience giving presentations and providing training, which requires ability to present in a classroom or virtual setting (public speaking skills) preferred. -Experience drafting IBC and IACUC approved policies preferred.
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