Regulatory Program Coordinator
Charlotte, NC, United States
Job ID: 81087
Job Family: Research Services
Status: Full Time
Detailed Shift and Schedule: M-F 8am-4:30pm
Job Type: Regular
Department Name: 55541005043201-Quality
Develops and manages internal operations and procedures of Institutional Review Board (IRB)/Institutional Animal Care and Use Committee (IACUC)/Institutional Biosafety Committee(IBC) related research and educational activities.
- Plans, coordinates and implements IACUC policies and administrative functions in accordance with federal regulations and accrediting agency policies and procedures.
- Supervises, develops, and coordinates the clinical research and education for IRB activities. Oversees the administrative functions of the IBC.
- Supervises and coordinates the IACUC federal regulatory management of research protocols.
- Assists in preparing the Guide for the Care and Use of Laboratory Animals as a basis for program evaluation.
- Coordinates inspection of animal facilities. Distributes inspection deficiency reports, and prepares inspection reports.
- Assists USDA inspector in the review of animal study files and meeting minutes, and prepares the annual report for the Office of Laboratory Animal Welfare (OLAW).
- Coordinates IACUC training for research staff and maintains training database, reviews applications for proposed research, and oversees annual review of IACUC Instruction Manual.
- Oversees payment of IACUC stipends to IACUC lay members.
- Ensures IRB compliance with federal regulations, IRB compliance with International Conference on Harmonization (ICH) Good Clinical Practice guidelines, revises informed consents with protocol reviews, and determines their appropriate category of review, assists in the oversight of other hospital departments for regulatory compliance.
- Assists in instructing Investigators and Research Support Staff in IRB, FDA and NIH regulations involving human subject research.
- Reviews research protocols involving the use of recombinant DNA and works with Investigators for needed follow-up actions.
Work requires standing, sitting, lifting, reaching, stooping, bending, pushing and pulling. Must be able to occasionally lift and support the weight of 15 pounds in handling equipment and supplies. Works in an office environment with periods of intense detail and deadline activities. Must be able to manage multiple priorities. Requires long periods of sitting, operating computer keyboard and telephone duties.
Education, Experience and Certifications
Associates Degree required. BSN preferred. Will consider candidate with years of experience. 2-3 years of previous research or research regulatory experience preferred.