Program Specialist (Research Compliance Officer)

Summary

The incumbent will serve as a Program Specialist - Research Compliance Officer at the Richard L. Roudebush VA Medical Center and reports to the Medical Center Director

Qualifications

To qualify for this position - applicants must meet all requirements by the closing date of this announcement - 04/28/2026. 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-12 position you must have served 52 weeks at the GS-11. 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 and/or education as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-11 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include - but are not limited to: developing - implementing - and maintaining oversight of compliance and training activities involved in research and development - as well as providing leadership - strategic direction and advising of regulatory policies for research 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/. Experience refers to paid and unpaid experience - including volunteer work done through National Service programs (e.g. - Peace Corps - AmeriCorps) and other organizations (e.g. - professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies - knowledge - and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience - including volunteer experience. Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. The full performance level of this vacancy is GS 12. Physical Requirements: The work is sedentary. Typically - the employee may sit comfortably to perform portions of the work. However - there is periodic walking - standing - bending - and carrying of light items such as medical records or binders - instructional materials - books and manuals. No special physical demands are required to perform the work. VA pre-placement physical examination is not required.

Duties

• Duties Works closely with the Chairman of Research and Development Committee (R&D) - Indiana University Institutional Review Board (IRB) - Indiana University School of Medicine (IUSOM) - VA Subcommittee for Research Safety - Deputy Chief of Staff for R&D (and the Administrative Officer for R&D) and Investigators to ensure compliance with laws and regulations promulgated to ensure the protection of human subjects in research
• Serves as the primary resource person concerning compliance issues in accordance with the \"Common Rule\" (45 CFR 46 & 38 CFR 16 & 17)
• Focuses especially on Department or Health and Human Service (HHS) - National Institutes for Health (NIH) - Food and Drug Administration (FDA) - and VA policies
• Communicates verbally and in writing with researchers to advise them on policy matters - process issues - and procedural requirements for conducting research involving humans
• Develops and revises - as necessary - written procedure documents implementing the regulations
• Monitors compliance with approved procedures and regulations by administration and by investigators
• Reviews all research projects involving human subjects - including thorough review of all informed consent documents
• Coordinates communication with Headquarters on Human Studies
• Responds to requests from the ORO
• Coordinates accreditation visits and other site visits that may occur by VA Headquarters - AAHRPP - FDA - OHRP - and/or ORO Develops a training program - ensuring it meets regulatory requirements - is modified accordingly to include current information - and is completed by appropriate staff members
• Works closely with the Veterinary Medical Officer - the Chairman of IUSOM - the Institution for Animal Care and IU's Subcommittee (IU JACUC) along with the Associate Chief of Staff for R&D and the Administrative Officer for R&D
• Monitors compliance of animal studies through the Animal Care and Use Subcommittee including developing criteria for continued review and compliance monitoring of all projects using animals
• Works with IUSOM IACUC to develop and revise - as necessary - any Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards - General Assurance with Office of Laboratory Animal Welfare Works closely with the Medical Center Safety Officer and Radiation Safety Officer - Chairman of the Institute of Biosafety Subcommittee - the ACOS for R&D and Administrative Officer for R&D - and the Research Safety Coordinator
• Monitors Safety Research Subcommittee activities to ensure compliance
• Develops and revises - as necessary - procedure manuals - Safety Plans - Chemical Hygiene Plans - and Biosafety Level 3 Standard Operating Procedure - and any other research compliance related documentation related to biosafety standards
• Works closely with the Medical Center Information Security and Privacy Officer - Chairman and Coordinator of Subcommittee on Human Studies - the ACOS for R&D - and Administrative Officer for R&D
• Monitors subcommittee reviews to ensure compliance
• Develops and revises procedure manuals as necessary Monitors the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Regulatory and Inspection standards as well as other federal regulatory bodies studies and publications concerning research compliance
• Coordinates facility correspondence with regulatory and inspecting agencies such as ORO - OIG - FDA and other regulatory agencies
• Work Schedule: 8:00am - 4:30pm Monday- Friday Telework: Ad-hoc with supervisory approval Virtual: This is not a virtual position
• Remote: This is not a remote position Position Description/PD#: Program Specialist (Research Compliance Officer)/PD93371-0 Relocation/Recruitment Incentives: Not Authorized