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. Responsibilities 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 Requirements Conditions of Employment You must be a U.S. Citizen to apply for this job To be considered for this position, you must complete all required steps in the process. In addition to the application and questionnaire, this position requires an online assessment. The online assessment measures critical general competencies required to perform the job. Selective Service Registration is required for males born after 12/31/1959 Physical Requirements: The work required does not inherently include any physical requirements essential for successful job performance that could not otherwise be performed with accommodation or workplace adjustment. A pre-placement physical examination is not required. Subject to background/security investigation Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period or 2-year trial period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. 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 https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/. Education There is no educational substitution at this grade level. Additional Information Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act. Reasonable Accommodation (RA) Requests: If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments. Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. VA may offer newly-appointed Federal employee's credit for their job-related non-federal experience or active duty uniformed military service. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. This job opportunity announcement may be used to fill additional vacancies. Career Transition Assistance Plan (CTAP) provide eligible displaced VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified: applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/.
