Program Specialist

Program Specialist (Institutional Review Board Liaison) in the office of the Associate Chief of Staff for Research and Development. The primary purpose of this position is as the Human Research Protection Program (HRPP) Manager in the Research and Development Administration and provides Quality Assurance and Quality Inspection for the Human Subjects Protection Program component of the Research Service. Provides primary administrative oversight of the Human Research Protection Programs (HRPP). Analyzes and evaluates, on a quantitative and/or qualitative basis, the effectiveness of the program's operations in meeting established goals and objectives. Analyzes program's performance data to identify issues related to human subjects' protection, compliance and reporting requirements, human subjects and good clinical practice (GCP) training requirements, accreditation, committee membership requirements, and Federal Wide Assurance (FWA) compliance. Responsible for keeping the Memorandum of Understanding (MOU) with the University of Utah Institutional Review Board (IRB) and other IRBs (Central IRB, National Cancer IRB) current with amendments as needed. Maintains current policies, procedures, and standard operating procedures (SOPs), provides oversight for all aspects of protocol submissions, reviews approvals, and renewal processes as well as post-approval administrative oversight and audits. Ensure compliance with the determination of research committees Services as the point of contact for communications with Office of Research Oversight (ORO). Prepares for and hosts oversite inspections. Is the lead on developing and implementing any remedial or corrective actions due to audits, inspections, other findings, and/or regulatory changes. Prepares all responses to oversight findings or suspensions. Completes audits of active research studies to ensure study procedures performed are as described in the approved IRB protocol. Primary oversight and management for regulatory compliance Work Schedule: 7:00 am 4:30 pm Compressed/Flexible: Available Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Position Description/PD#: Program Specialist/PD125380 Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): Not Authorized