Health System Specialist (Research Compliance Officer)

This position is organizationally aligned to the Office of the Hospital Director at the Edward Hines Jr. VA Hospital (578) • a Level 1a Complexity VHA Facility. The primary purpose of this position is to develop, implement, maintain and provide leadership, strategic direction, and oversight of compliance and training activities for the Research Program. Hines VAMC includes five community-based outpatient care clinics located in Aurora, Hoffman Estates, Joliet, Bourbonnais, Peru, and Oak Lawn. The Research Compliance Officer (RCO) evaluates compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: Protection of human research subjects, laboratory animal welfare, and research safety and security. Incumbent may also be assigned responsibilities related to facility programs for research information security, research privacy, conflict of interest in research, training of research personnel. Research program accreditation, research misconduct, and/or other research compliance activities consistent with VHA requirements. As a public agency, VHA has an obligation to preserve public trust in the integrity and quality of research carried out by its investigators, involving subjects in VA research, and in its facilities. Appropriate mechanisms must be in place to evaluate the functioning of the Human Research Protection Program (HRPP) and the safeguards in place to protect human research subjects in VA research. There must also be appropriately trained staff available at each VA facility conducting human subjects' research to audit each research project involving human subjects. The RCO leads the facility's research compliance program by providing expertise, strategic direction, and oversight. The role includes collaborating with senior health system and research leaders, developing compliance strategies, policies, and standards, evaluating program effectiveness, analyzing performance trends, and preparing compliance status reports. Duties may include, but are not limited to the following: Audits, Inspections, and Management Controls • 50% Develops and evaluates research compliance control systems, procedures, and audit processes. Audits human-subject and animal-subject research records for compliance with applicable regulations, standards, and accreditation requirements. Updates standard operating procedures and provides guidance on research compliance. Supports compliance across human and animal studies, laboratory and radiation safety, conflict of interest, information security, and privacy programs. Maintains complete and timely audit records, administrative and quantitative reports, and trend analyses. Ensures records are accessible to authorized officials and federal investigators and retained for potential ORO, FDA, ORD, USDA, and AAALAC inspections. Documents audits, inspections, management controls, serious or continuing noncompliance, unanticipated problems, systemic deficiencies, and other reportable events. Prepares and submits routine, for-cause, consolidated, and management reports to research review committees, facility leadership, national program offices, ORO, and applicable federal agencies. Performs quality assurance and quality management activities to prevent noncompliance, identify unfavorable trends, and correct contributing factors. Identifies systemic deficiencies that may compromise research protections or information security and ensures prompt reporting and follow-up. Develops and Maintains Working Relationships • 10% Maintains effective working relationships with the Information Security Officer, Privacy Officer, IRB, IACUC, research safety officials, radiation safety officials, and other relevant stakeholders. Provides routine compliance reports to the Health System Director and other facility leaders in accordance with VHA and facility requirements. Standards, Regulations, and Policy Development • 10% Disseminates regulatory and policy updates to research administrators, oversight committees, investigators, research personnel, and facility leadership. Serves as the local resource for regulations, policies, memoranda, alerts, and federal requirements related to research compliance. Maintains timely and open communication regarding research compliance issues. Training and Consultation • 10% Advises investigators, research coordinators, research committees, medical center leadership, and researchers on compliance practices and VA and federal regulatory requirements. Consults on the development and revision of Research Service and other facility standard operating procedures. Develops education and training materials related to research compliance auditing and regulations. Performs other related duties as assigned. Work Schedule: Monday- Friday 7:30am • 4:00pm Telework: This position is not authorized for telework. Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist (Research Compliance Officer)/PD030540 Relocation/Recruitment Incentives: Not Authorized. To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/09/2026. 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 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. You may qualify based on your experience and/or education as described below: The Health System Specialist occupation has an Individual Occupation Requirement that must be met to qualify for the position. 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: 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 addition to meeting the Individual Occupational Requirement, you may qualify for this position based on your experience and/or education as described below: GS-12 Qualification Requirements: Specialized Experience GS-12: You must have at least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-11) in the Federal Service in the normal line of progression for the occupation in the organization, that is typically in or related to the work of this position and has equipped you with the knowledge, skills, and abilities to perform successfully duties of the Health System Specialist (Research Compliance Officer). Examples of specialized experience would typically include (but are not limited to): Comprehensive knowledge of Federal and VA research regulations, human-subject protections, research safety and security requirements, administrative policies, and legal precedents and the operational and funding requirements governing publicly and privately supported medical research programs. Expertise in auditing and monitoring research projects, documenting findings, and report to oversight committees; analyzing compliance data and performance trends; preparing reports; developing improved compliance procedures; communicating clearly with senior staff, researchers, affiliates, and administrators; building positive stakeholder relationships; delivering audience-appropriate training and consultation; and using databases, information systems, telecommunications equipment, and business software to support research compliance activities. The ability to lead and provide strategic direction for research compliance programs, establish and maintain effective oversight activities, and address complex interdisciplinary issues with resourcefulness and innovation. It also involves developing strong working relationships with key stakeholders, including information security, privacy, institutional review, animal care and use, research safety, and radiation officers. In addition, the position requires independent judgment, effective planning, and adaptability to changing regulations, technologies, and program requirements. • OR- Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 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 a combination of specialized experience and education beyond master's or equivalent graduate degree or 2 full years of progressively higher-level graduate education leading to such a degree or LL.B. or J.D., if related. Preferred Experience: Prefer individual with experience evaluating compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: the protection of human research subjects, laboratory animal welfare, and research safety and security. Experience in research information security, research privacy, conflict of interest in research, training of research personnel. Research program accreditation, research misconduct, and/or other research compliance activities consistent with VHA requirements. Physical Requirements: Work is mainly sedentary. Traveling off station to other sites of care or various meetings is necessary and working overtime and odd hours, to include weekends may be necessary. There may be some walking, standing, bending, carrying of light items, such as instructional material, manuals, papers, and books. 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/. You must be a U.S. Citizen to apply for this job. Selective Service Registration is required for males born after 12/31/1959. Must be proficient in written and spoken English. 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. 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 dentification 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 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 trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. There is no educational substitution at this grade level. A transcript must be submitted with your application if you are basing all or part of your basic 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/.