MD Anderson Cancer Center Research Regulations Specialist - PAM Monitor for Enhanced Research Oversight & QA Program in Houston, Texas
The Research Regulations Specialist will work with the Institutional Animal Care and Use Committee (IACUC) . The IACUC Post-Approval Monitor ensures 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 will have a Bachelor's degree in Basic Science, Animal Science, Healthcare or related field and five years of experience in pre-clinical research, regulatory compliance or related field. Recent animal research experience is a plus. Lab research experience or a scientific background is highly desired.
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.
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.
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.
Acts 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.
Other duties as assigned.
Education: Bachelor's degree in a Basic Science, Animal Science, Healthcare or related field.
Experience: Five years of experience in pre-clinical research, regulatory compliance or related field.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Requisition ID: 151566
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Hard
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Minimum Salary: US Dollar (USD) 62,500
Midpoint Salary: US Dollar (USD) 78,000
Maximum Salary : US Dollar (USD) 93,500
Science Jobs: No
MD Anderson Cancer Center
- MD Anderson Cancer Center Jobs