Senior Compliance Administrator
Requisition # 2018-8646
Department Research Integrity & Assurance
Category Research and Laboratory
Full-Time / Part-Time Full-Time
The Research Integrity and Assurance office at Princeton University is seeking an individual 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. Integral to this program will be scheduled visits to labs, facilities, field stations, or sites where these activities occur. The employee must maintain a thorough working knowledge of, and ability to apply, federal regulations, policies and guidelines pertaining to animal welfare, work with biohazardous agents, and human subjects' protections, ,outreach and training to educate the research community about the regulations associated with research compliance within the investigator's specific area of research. The employee will provide administrative support to the IACUC Assistant Director, IRB Assistant Director, and the IACUC and IRB Compliance Administrators as needed.
Specific Job Functions:
- Post-approval monitoring for animal, biosafety, and human 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, EHS), IACUC, IBC, IRB and/or state and/or federal and/or independent accrediting body
- Develop responsible corrective action plans to address areas of non-compliance, animal welfare of 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
- 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 be able to communicate those findings to the investigators and their labs. Prepare reports in order to present PAM “findings” at convened IACUC, IBC, and IRB meetings as needed to share necessary information.
- Training and outreach (tailored to, and based upon departmental, laboratory, or individual needs) designed to 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.
- 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
- Initiate, coordinate, and track inter-institutional agreements for the IACUC, IBC, and IRB
- Assist with implementation of electronic protocol management system.
- Provide support to IACUC, IRB or IBC during absences
- Bachelor's degree
- Strong understanding of the scientific process and method. Background in research or grantsmanship preferred.
- Demonstrated understanding of research compliance issues and regulatory agency requirements
- Demonstrated proficiency in developing, writing and implementing institutional policies and procedures
- 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.
- Knowledge of human social behavioral research paradigms, consents forms, and special regulatory requirements around work with children, prisoners, pregnant women, or individuals with high risk diseases or other incapacities
- 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
- Ability to read and understand scientific documents such as research protocols, grants, regulations, and policies
- Proficient computer skills, which includes MS Office applications and database applications.
- Superior critical thinking, writing, and editing abilities
- Excellent interpersonal and customer service skills, including the ability to interact effectively with a diverse constituent population
- Must be detail oriented, possess superb organizational skills, and be able to schedule and make forward progress on multiple projects simultaneously
- Ability to work independently and as a member of a team
- Evidence of successful experience in a customer service role
- High degree of personal integrity and ethics with uncompromising standards
- PRIM&R Certified Professional IACUC Administrator (CPIA®)
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. EEO IS THE LAW
Standard Weekly Hours
Eligible for Overtime
Essential Services Personnel (see policy for detail)
Physical Capacity Exam Required
Valid Driver's License Required
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