<p>The Program Specialist, whose working title is Research Compliance Officer (RCO), is organizationally located in the Lebanon Department of Veterans Affairs Medical Center's Office of the Director. The position reports directly to the Medical Center Director and works jointly with the Chief of Staff (COS), the Associate COS/Research, the Administrative Officer for Research, all research programs (including clinical and academic programs that have a research component), and research committees.</p> <p>Duties include:</p> <ul> <li>Ensures research program compliance in the areas of credentialing, training and education of investigators and research staff. The RCO is responsible for reviewing the credentialing, privileging, and training of all investigators and staff to ensure that all personnel conduct research within their scope of practice. And ensure that all personnel are appropriately vetted to interact and conduct research on veteran and non-veteran subjects </li><li>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. </li><li>Serves as a consultant on all Human Research Protection Program (HRPP) meetings including Institutional Review Board (IRB) and Research and Development Committee (R&D). </li><li>Conducts quality assurance reviews of the HRPP to identify potential noncompliance trends and develop plans for remediation. </li><li>Communicates with affiliate Universities and VA's that participate in collaborative research ensuring that all involved organizations are committed to adhering to high standards of ethics, integrity, and responsibility in their research programs. </li><li>Plays a critical role in the preparation and application for accreditation of the facilities Human Research Protection Program (HRPP). </li><li>Works closely with other departments such the Office of Research Oversight (ORO) regarding review of Human Research Protection Program (HRPP) activities, including development of remediation plans, initial and follow-up reports. </li><li>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 (DHHS), National Institutes of Health (NIH), Food and Drug Administration (FDA) </li><li>Reviews Institutional Biosafety Committee (IBC) / Safety Research Subcommittee (SRS) activities, records (including databases and meeting minutes) to ensure compliance with VHA, State, NIH, national and other regulatory body requirements as needed. </li><li>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. </li><li>Advise and assist management in investigations following accidents and incidents </li><li>The RCO communicates regularly with the Institutional Biosafety Officer for Research (IBSO / R) ensuring staff compliance with safety policies and procedures by performing regular safety inspections, and documenting and submitting reports to the IBC / SRS Committee for review and action. </li><li>Assist in the preparation of standard operating procedures for the safe use, storage, transport, and disposal of biohazards. </li><li>Conducts quality assurance reviews of the IBC / S RS program to identify potential noncompliance trends and develop plans for remediation. </li><li>Contributes to the process for ensuring that any Conflict of Interest that an Investigator may have in connection with a Research Project is fully disclosed, reviewed in accordance with established procedures, and satisfactorily resolved before the Research Project is initiated, regardless of funding. </li><li>Assists the COI Committee with providing written notification to investigator about its findings and actions. </li><li>Develops processes, procedures and training modules related to research matters pertaining to Conflict of Interest. </li><li>Other duties as assigned. </li></ul> <p>Work Schedule: Monday-Friday 7:30 am - 4:00 pm or 8:00am - 4:30pm</p> <p>Telework: AdHoc Only. Telework eligibility will be discussed during the interview process.</p> <p>Virtual: This is not a virtual position.</p> <p>Position Description/PD#: Program Specialist - Research Compliance Officer/PD039080</p> <p>Relocation/Recruitment Incentives: May be authorized for highly qualified candidates.</p>