Summary The Research Compliance Officer (RCO) is responsible for providing strategic direction and developing, implementing, and documenting a comprehensive program to ensure compliance of Research and Development (R&D) activities conducted by Robley Rex VA Medical Center (RRVAMC). Join RRVAMC during this exciting time as we transition to a new hospital beginning in 2026. New Louisville VA Medical Center | VA Louisville Health Care | Veterans Affairs Responsibilities The RCO reports directly to the Executive Director. The incumbent will work closely with the Office of Research Oversight, the RRVAMC Executive Leadership Team, Integrity and Compliance Office, the R&D leadership and staff, facility staff, our affiliates (such as University of Louisville, Galen College of Nursing, etc.), and the non-profit Clinical Research Foundation, Inc. to ensure compliance with federal regulations and policies at the national, regional, and local levels. Duties include but are not limited to: Analyzes and evaluates, on a quantitative or qualitative basis, the effectiveness of programs and operations in meeting established compliance goals and objectives. Develops procedures and systems for establishing, operating, and assessing the effectiveness of compliance control systems and the accomplishment, evaluation and/or monitoring of audits, inspections, or management of internal control reviews. Ensures safety and compliance with the following: protecting patient information, patients' use of diagnostics, medications, and therapeutics. Designs standards and policies that effectively enable researchers and others to meet compliance requirements. Serves as a back-up to the Integrity and Compliance Officer as needed with program management, evaluation, monitoring, auditing, and reporting. Ensures compliance by protecting the rights, welfare, and wellbeing of human subjects involved in research. Maintains accreditation of the facility's Human Research Protection Program (HRPP) by the Association for the Accreditation of Human Research Protection Programs(AAHRPP). Serves as the primary liaison with outside entities concerning compliance issues in accordance with the "Common Rule" ( 45 CFR 46) and other regulations and policies of the Department of Veterans Affairs, Department of Health and Human Services, National Institutes of Health, Food and Drug Administration, Commonwealth of Kentucky, University of Louisville and other affiliates, and RRVAMC. Reviews Research Safety and Biosafety records (including databases and meeting minutes) to ensure compliance with national requirements, including those of the Department of Veterans Affairs, Occupational Safety and Health Administration, Nuclear Regulatory Commission, Environmental Protection Agency, and the National Institutes of Health. Conducts fact findings, Administrative Investigation Boards (AIB), or other formal investigations as necessary to identify root causes when deficiencies or instances of non-compliance are found. Coordinates work related to information security issues and privacy concerns with the Information Systems Security Officer and Privacy/FOIA Officer and collaborates with them in making recommendations as indicated to ensure protection of sensitive and non-sensitive data. Serves as a regular or ad hoc member of committees outside of Research Compliance, such as the Integrity and Compliance Committee, as determined appropriate. Performs other duties as assigned. Work Schedule: Monday-Friday 8:00am - 4:30pm Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist (Research Compliance Officer)/PD403950 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 Selective Service Registration is required for males born after 12/31/1959 You may be required to serve a probationary period Subject to background/security investigation Selected applicants will be required to complete an online onboarding process Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details. Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 02/03/2025. 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. Individual Occupational Requirements (IOR): Undergraduate and Graduate Education: Major study -- hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. OR Specialized Experience: (for positions above GS-5): Progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field. This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities. Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities, and provided knowledge of the following. Such experience may have been gained as an administrative officer, management analyst, or administrative or clinical program manager or supervisor in a health care delivery system. Missions, organizations, programs, and requirements of health care delivery systems; Regulations and standards of various regulatory and credentialing groups; and Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement. Special Provision for In service Placement: Successful completion of an agency-sponsored on-the-job training program may be substituted for qualifying experience, provided it included a formal individualized training plan. Such a training program must have been conducted in an operating health care system and included: Assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; Practical assignments providing an opportunity to apply health system administration skills and principles (as the individual progresses, work assignments must be characteristic of the grade level to which he or she is assigned); and Oversight by an experienced health system administrator with periodic evaluation of the individual's progress and appropriate adjustment of the training program. In additional to the IOR requirement you must meet one of the below options. 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-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: experience working within a health care setting providing leadership, strategic direction, and oversight of compliance activities; ensuring a standardized and effective approach to compliance using the compliance framework, compliance and Integrity standards, processes, and resources; and experience using complex analytical problem-solving methods, principles, and theories to identify extensive program data and conduct a variety of studies and investigations, experience with research studies. OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. OR, Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond a master's degree) and specialized experience as described above to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position {i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). NOTE: Transcripts must be submitted with your application materials. Education cannot be credited without documentation. Experience must be clearly indicated in your resume. You will be rated on the following Competencies for this position: Analysis and Problem Solving Audit Reporting Communications Compliance 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. Physical Requirements: The work requires no unusual physical demands, but it does require good speaking ability (for education and training purposes) and manual dexterity (computer keyboard skills). It is sedentary, requires walking, standing, bending, and carrying light items. 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 A transcript must be submitted with your application if you are basing all or part of your qualifications on education. Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. Additional Information Receiving Service Credit or 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. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. 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. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. 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.