Research Regulations Specialist

The Research Regulations Specialist working with the Institutional Animal Care and Use Committee (IACUC) will ensure that activities with animal subjects used in research are compliant with institutional policies, procedures, ethical principles and government regulations by identifying and enhancing compliance opportunities through post-approval monitoring (PAM) activities.   

The ideal candidate must have experience working in animal research facilities. Other lab/research experience is a plus.

KEY FUNCTIONS

Post Approval Monitoring (PAM) Program Manager for the IACUC   

• Ensure all animal research activities are being conducted in accordance with institutional policies, IACUC procedures, government regulations and ethical principles.
• Conduct all PAM activities including scheduling, coordinating, participation, documentation and ensuring follow up. Recommend best practices including research policies and record keeping requirements.
• Provide regular reports of PAM activities. Work with the Institutional Animal Care and Use Committee (IACUC), Research Oversight and Integrity team, Department of Veterinary Medicine and Surgery, Department of Epigenetics and Molecular Carcinogenesis and Department of Comparative Medicine to develop an effective program of post-IACUC protocol approval monitoring to ensure compliance with applicable research guidelines (NIH OLAW, USDA, AAALAC accreditation) throughout MD Anderson. 
• Work to develop, cultivate, and maintain constructive working relationships with investigators, institutional administrators, and internal departments.
• Collaborate with IACUC staff, veterinary staff, and researchers to develop, implement, or revise institutional policies and procedures to help ensure compliance. Responsible for preparing and distributing timely reports according to the program of post-IACUC approval monitoring and provide related program metrics to the IACUC committee and staff. 
• Responsible for building and maintaining a usable database management system for the post-IACUC approval monitoring program.
• Responsible for recommending improvements to processes and training delivered through the IACUC office. Maintain confidentiality as appropriate.
• Establish with the Principal Investigator (PI) a suggested correction action plan to the IACUC for any post-approval monitoring findings and monitors the corrective action to ensure its completion by the correct date approved by the IACUC.
• Work with the principal investigator to self-report unanticipated adverse events or events of noncompliance to the IACUC as appropriate and assist in the development and implementation of monitoring processes and improvement action plans.
• Coordinate and participate in inspections of animal care and use facilities and laboratories to assist the IACUC in providing oversight of all animal-related activities and to ensure compliance with federal regulations, nationally accepted standards and institutional policies.
• Conduct for-cause and not-for-cause audit visits by interviewing and/or observing the PI and his/her research team with respect to IACUC approved, active protocols.
• Conduct post-approval monitoring activities by assessing PI and Research Team compliance with terms of approved animal research protocols.

Administrator  

• Develop PAM action plans from federal guidelines and internal policies.
• Develop and maintain reports to monitor compliance trends, and inform stakeholders about trends, risk areas, and educational needs.
• Develop work priorities based on institutional needs and regulatory areas.
• Coordinate, facilitate, and participate in regulatory inspections/site visits.
• Assist in the development and maintenance of standard operating procedures (SOPs), guidelines, policies, and procedures. Assist with other IACUC duties during high volumes of submissions or absences.
• As needed and requested, assist in preparing the meeting agendas and minutes, scheduling monthly committee and leadership meetings, conducting administrative protocol pre-reviews including verification of training, all relevant sections of the protocol are completed appropriately, hazardous and biological materials review, and proper routing of the protocol.

Institutional Resource  

• Assist in the development and implementation of PAM education programs.
• Monitor research regulatory changes including federal, state and local compliance. 
• Participate in initiatives and strategic plans including programmatic changes based on updated regulations and or site visit recommendations.
• Serve as a resource to the PI in discussing the animal research protocol with a Designated Member Reviewer of the IACUC or in preparing the submission for Full Committee Review.
• Assist principal investigators and research teams with annual renewals, 3-year renewals and amendments.
• Act as a contact for specialized technical support and regulatory compliance analysis to the research faculty and staff that allows for extensive networking within the institution. Assist in other areas and duties as needed as assigned.