Program Specialist - Research Compliance Officer

Full Job Description

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.

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/.

Major 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.