Health System Specialist (Research Compliance Officer)

Veterans Health Administration • Hines, IL

18d • Onsite

About The Position

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.

Requirements

• 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.
• 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.
• 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.
• Major study- hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration.
• Progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field.
• 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).
• 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.
• Developing strong working relationships with key stakeholders, including information security, privacy, institutional review, animal care and use, research safety, and radiation officers.
• Independent judgment, effective planning, and adaptability to changing regulations, technologies, and program requirements.
• 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.
• 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.
• A transcript must be submitted with your application if you are basing all or part of your basic qualifications on education.
• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Benefits

• A career with the U.S. government provides employees with a comprehensive benefits package.
• As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.
• 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.
• Such credit must be requested and approved prior to the appointment date and is not guaranteed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree