Program Specialist

Program Specialist

Duties include but are not limited to:

• Coordinate with the Research Service; Research Pharmacy; and Radiation Safety; and R&D Committee/Subcommittees to ensure the ethical conduct of research for all GLA, Non-profit, and Academic Affiliate-projects involving human subjects.
• Work closely with the HRPP Administrator and the Institutional Review Boards (IRBs) in ensuring continuing accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
• Develop appropriate audit tools and conduct routine and "for cause" audits of the HRPP program including, but not limited to: informed consent monitoring, protocol audits, investigation device audits, investigation drug audits and verification that all research is approved by the V A Research and Development Committee.
• Prepare audit reports and compliance analysis, including recommendations for quality improvement and performance standards for review by the RCO.
• Coordinate with the Veterinary Medical Officer (VMO) and the Institutional Animal Care and Use Committee (IACUC) in insuring continuing accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
• Work closely with the Bio-safety Subcommittee and Radiation Safety to ensure that animal laboratory self-inspections are completed and deficiencies corrected, and that any bio-safety issues are identified on proposals for review submitted by Investigators.
• Identify, report, and correct problems related to the ethical conduct of research, issues of conflict of interest, and issues involving intellectual property rights.
• Training of Investigators, Research Staff, Research Committee and Subcommittee Members and Research Administrative Staff.
• Facilitate and participate in compliance education opportunities, including presentations at local and national meetings.
• Exercise judgment and ensure that any patient safety issues revealed during audits are communicated to the principle investigators promptly in lieu of a formal report.
• Assist in the development of new research compliance assurance technologies, including the evaluation and refinement of a computer-based compliance software package.
• Attend and participates in appropriate meetings including VISN Research meetings, and ORD directed site visits, training and travel.

Work Schedule: Monday-Friday from 8:00am-4:30pm

This is not a virtual position.

Position Description/PD#: PD078770