Program Specialist - Research Compliance Officer

Summary This position is organizationally located in the Office of the Director at the Lebanon Veterans Affairs Medical Center (LVAMC) in Lebanon, PA. This position reports directly to the Medical Center Director and works collaboratively with the Chief of Staff (COS), the Associate COS (ACOS) for Research & Development (R&D), the Administrative Officer for R&D, all research programs (including clinical and academic programs that have a research component), and all research committees. Learn more about this agency Duties ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** MAJOR DUTIES: Ensures research program compliance in the areas of credentialing, training, and education of investigators and research staff. Reviews all research projects involving human subjects, including but not limited to a thorough review all informed consent documents, research protocols, safety, and quality measures established to protect research personnel as well as Veteran and non-Veteran subjects. Serves as a consultant on all Human Research Protection Program (HRPP) meetings including Institutional Review Board (IRB) and R&D Committee(s). Conducts quality assurance reviews of the HRPP to identify potential noncompliance trends and develop plans for remediation. Reviews Institutional Biosafety Committee (IBC)/Safety Research Subcommittee (SRS) activities and records (including databases and meeting minutes) to ensure compliance with VHA, State, NIH, national and other regulatory body requirements as needed. Assures safety and compliance by conducting biosafety-related inspections and other monitoring activities by assisting PIs and IBC members in the review and approval process. Evaluates compliance with federal, state and VA requirements for the conduct of research, which may include requirements in the protection of human research subjects and/or research safety and security. Assigned areas of responsibility are dependent upon the needs of and its research programs in meeting VHA auditing, monitoring and related research protection and oversight requirements. The incumbent performs ongoing research auditing in assigned areas of responsibility. These activities must be consistent with VA research auditing requirements and require the ability to conduct in-depth review and analysis of research, clinical, and training records. Reports findings and recommendations of review, audit and/or investigation activities to the Medical Center Director, COS, ACOS for R&D, and R&D Committee. Analyzes and evaluates, on a quantitative or qualitative basis, the effectiveness of programs and operations in meeting established compliance goals and objectives and prepares program status reports for review at all levels. 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. Participates in the development and delivery of education and training for research employees regarding compliance requirements. Works closely with the R&D management and staff to ensure compliance with federal regulations and policies at the national, regional, and local levels. Performs other related duties as assigned. Work Schedule: Monday-Friday, 8:00am to 4:30pm Recruitment & Relocation Incentives: May be authorized for highly qualified candidates. Critical Skills Incentive (CSI): Not approved Telework: This position may be authorized for ad hoc telework. Telework eligibility will be discussed during the interview process. 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: Typically, the employee sits comfortably to do the work. However, there may be some walking, standing, bending, and carrying of light items such as papers, books, or records. May be required to drive an automobile. No special physical demands are required to perform the work. 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) - See "Required Documents" below for details. As a condition of employment for accepting this position, you will be required to serve a 1-year probationary 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, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications Specialized Experience (GS-12): Applicants must have one (1) year of specialized experience equivalent to at least the GS-11 level in the Federal service. Specialized experience: Performing verifiable research auditing of a wide range of medical research activities (e.g. pharmaceutical, mental health services, social services, physical health, tumor and tissue research, behavioral and other non- biomedical methods, and laboratory research) to include ensuring the protection of human research subjects. This experience must be demonstrated on your resume to receive credit. 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 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. 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. 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. The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 80 or more before any Veterans preference points) for this vacancy. 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/. Note: Per "Executive Order 14251: Exclusions from Federal Labor-Management Relations Programs", this position is no longer eligible for bargaining unit participation. Expand Hide  additional information Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. 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. Opens in a new windowLearn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.