The Research Integrity and Assurance office at Princeton University is seeking a Post-Approval Monitor (PAM) to assist the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and Institutional Review Board (IRB) with monitoring the conduct of research and teaching activities. Active protocols will be monitored following IACUC, IBC or IRB approval to ensure that research and teaching activities involving animals, biohazardous agents, or human subjects are performed in accordance with federal, state, local and institutional requirements. This individual will schedule visits to labs, facilities, field stations, or sites where these research and/or teaching activities occur. This role will assist in the follow-up and training of corrective action plans implemented by adverse event reporting or committee recommendations. The employee must maintain a thorough working knowledge of all federal regulations, policies and guidelines pertaining to animal welfare, work with biohazardous agents, and human subjects’ protections. This role will provide outreach and training to educate the research community about the regulations associated with research compliance within the investigator’s specific area of research. The Post-Approval Monitor will provide administrative support to the IACUC Associate Director, IRB Associate Director, and the IACUC, IBC, and IRB Compliance Administrators as needed.
Responsibilities
Post approval Monitoring: -Meet the regulatory requirements for continuing review of IACUC, IBC, and IRB written protocols to ensure that they are being followed in the laboratory or in the field. -Ensure no research is occurring unless it has been reviewed and approved by the appropriate regulatory body. -Perform training and outreach to students and faculty on regulatory compliance issues associated with animal, biohazardous, and human subjects matter research. -Follow escalation strategies for areas noted during post-approval monitoring that involve non-compliance, animal welfare, or increased risk to human subjects to enable appropriate reporting of findings to the PI and/or University (RIA, LAR, NRP, EH&S), IACUC, IBC, IRB and/or state and/or federal and/or independent accrediting body. -Develop corrective action plans to address areas of non-compliance, adverse events, animal welfare, or increased risk to human subjects in order to mitigate potential risks to the University. -Review IACUC, IBC and IRB protocols and develop an appropriate audit or monitoring plan commensurate with regulation, risk level, species and procedure. -Attend all IACUC, IBC and IRB meetings and review agenda items prior to meeting. -Review IACUC, IBC and IRB protocols for overlap and congruency. -Meet with investigators and their labs for one-on-one conversations; observe procedures, review documents. -Document findings and be prepared to give an exit debriefing of overall findings to the lab at the time of departure. -Develop written reports of compliance-related findings and communicate those findings to the investigators and their labs. -Prepare reports to present PAM findings at convened IACUC, IBC, and IRB meetings as needed to share necessary information. -Participate in semi-annual program review and facility inspections with the IACUC. -Assist in end-of-year report generation based on the compliance needs. -Assist during regulatory inspections by federal inspectors, site visitors, or auditors. Act as subject matter expert to present program of post approval monitoring to inspectors, auditors, and visitors. -Serve as key contributor/author in drafting appropriate remedial or mitigating correspondence with regulators. -Perform congruency reviews by reading sections from grant proposals and comparing them to IACUC, IBC, and/or IRB approved protocols.
Training and outreach: Tailored to departmental, laboratory, or individual needs. Educate the Princeton research community about regulations, policies and guidelines concerning animal, biosafety and human subjects research. Such training may involve occasional work after hours. Provide training based on approved corrective action plans.
Protocol review:
-Review all agenda items for potential compliance concerns. -Help to facilitate amendment submission and approval. -Provide necessary regulations or institutional policies for reference as needed. -Participate in collaborative meetings with LAR/NRP/IBC/BSO/IRB/EH&S as needed to facilitate compliance.
Other responsibilites:
-Assist with eRIA electronic protocol management system as needed. -Provide help to gather data needed for regulatory reporting. -Provide first line support for research personnel or committee members -Provide protocol review comments within the system -Perform testing and recommendations for upgrades
-Provide backup support to compliance administrators as needed. -Cross train in all areas of IACUC, IBC, and IRB administrative support -Assist in meeting preparation, agendas, and minutes as needed.
Qualifications
Essential qualifications:
-A minimum of 7 years of experience supporting human and/or animal and/or work with biohazardous agents in a research setting in higher education or related field. -Extensive knowledge of PAM in an academic research environment. -Knowledge of USDA, AAALAC, OLAW, OBA, OHRB regulations and guidance. -Ability to read and understand scientific documents such as research protocols, grants, clinical records, regulations, and policies -Demonstrated proficiency in developing, writing and implementing institutional policies and procedures -Knowledge of human social behavioral research paradigms, consents forms, and special regulatory requirements involving work with children, prisoners, pregnant women, or individuals with high risk diseases. -Demonstrated strong understanding of research compliance topics and government requirements specific to animal research and work with biohazardous agents including the Animal Welfare Act and Regulations, the Guide for the Care and Use of Laboratory Animals, the PHS Policy on Humane Care and Use of Laboratory Animals, AVMA Guidelines for the Euthanasia of Animals, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Biosafety in Microbiological and Biomedical Laboratories, and other relevant texts, policies, guidelines, and procedures. -Knowledge of animal techniques including: anesthesia, analgesia, blood collection, drug administration, aseptic technique as well as recognition of normal animal behavior and appropriate handling of animals used for teaching and research -Knowledge of appropriate safety precautions when working with biohazardous agents -Proficient computer skills, which includes MS Office applications and electronic database applications. -Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented -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. -Ability to work independently and as a member of a team -Evidence of successful experience in a customer service role
Preferred Certifications and Qualifications: -PRIM&R Certified Professional Institutional Animal Care and Use Committee (IACUC) Administrator (CPIA) and/or PRIM&R Certified Institutional Review Board (IRB) Professional (CIP) -CMAR/LATG certification from the American Association of Laboratory Animal Science
-Familiarity with electronic protocol review/management systems 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 policies/guidelines/SOPS preferred.
Princeton University is an Equal Opportunity/Affirmative Action Employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, or any other characteristic protected by law. KNOW YOUR RIGHTS
