Program Specialist

Summary 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. Qualifications To qualify for this position - applicants must meet all requirements by the closing date of this announcement - 06/26/2026. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-11 position you must have served 52 weeks at the GS-09. The grade may have been in any occupation - but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year - it may not clearly demonstrate you possess one-year time-in-grade - as required by the announcement. In this instance - you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-09 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include - but are not limited to: Performing structured reviews - identifying routine compliance issues working with senior Quality Assurance/Quality Improvement (QA/QI) and Human Research Protection Programs (HRPP) staff. Supporting development of quality control plans by gathering and organizing data on research processes - reviewing study procedures for alignment with policy. Using basic qualitative and quantitative techniques to review and research documentation - identifying patterns and discrepancies - preparing summary notes. Applying all regulations - laws - policies etc. to routine tasks and seeking guidance on complex or novel regulatory interpretations. For more information on these qualification standards - please visit the United States Office of Personnel Management's website at Duties 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 oversight 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 #J-18808-Ljbffr