This position serves as Health System Specialist - Research Committee Manager within the Research and Development (R&D) Service. The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden.

Duties

Duties and responsibilities include but are not limited to: R&D, IRB, IACUC, SRS, CIRB, IBC, and/or HRPP Program Administration Oversees and manages these programs and their activities, including preparation of committee and reviewer materials with appropriate documentation, ensuring projects are reviewed by appropriate personnel, and ensuring all outstanding issues related to project management are resolved in a timely manner. Serves in an advisory capacity to the R&D Leadership, research investigators, research committee members, and research committee Chairs and others on issues relative to carrying out the institution's research activities involving the use of humans, animals, and safety procedures for investigative purposes. Oversees the protocol review process of multiple programs and committees, ensuring projects are reviewed by appropriate personnel, including the Information System and Security Officer (ISSO) and Privacy Officer (PO), and issues related to project management are resolved. Develops and maintains a pre-review program that will coincide with the IRB, IACUC, SRS, IBC, CIRB, and/or R&D Committee review of all research involving human subjects, animal subjects, basic laboratory science and the human research protection program. Develops and manages required annual and semi-annual reviews of the assigned programs to include Animal Care and Use Program (ACUP), Human Research Protection Program (HRPP), Research Safety and Security Program (RSSP), as well as developing and managing the post approval monitoring program for assigned committees. Educates the investigative community of local and external policies and procedures with regards to research involving animal and human subjects. Develops reporting procedures, sampling techniques, and measurements at various points in the research committee process and research programs to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content. Quality and Compliance Responsible for maintaining the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered. Responsible for maintaining the IBC registration with the National Institutes of Health Office of Science Policy and ensuring IBC is appropriately constituted and registered. Responsible for maintaining the program's accreditation process for the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC). Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, OHRP (Office of Human Research Protection), ORO, and other applicable regulatory and procedural requirements. Develops programs, policies, and procedures within the Research Office to ensure that quality provisions are planned, developed, and implemented to identify, prevent, and correct unsatisfactory conditions and elements which influence the regulatory correctness and responsiveness of submissions, services, safety, animal, and human subject research. Monitors quality assurance program implementation and indicators designed to prevent erroneous transactions and ineffective work practices and to verify adherence to quality assurance plans and requirements. Responsible for alerting investigators of deficiencies found within their submissions and educating them as to the steps required to correct the deficiencies. Administrative Oversight Assumes responsibility in preparing for all external reviews such as: FDA, USDA, ORO, NIH OSP, AAALAC, OHRP, and OLAW, which includes securing all necessary documents and demonstrating practices to reflect full compliance. Provides advice and consultation to IRB, SRS, IACUC, and R&DC chairs, members and staff on ethical principles, laws, regulations, and policies governing the review and approval of human subjects' research, animal research and safety protocols. Research and/or analyzes problems, administrative issues, or program requirements as they relate to animal, human subject or safety research and the research review process. Initiates or reviews correspondence for all research projects and oversees the maintenance of project and correspondence files as well as assembling background information, reports, and attachments by obtaining information from staff, literature, and files. Work Schedule: M-F 8:00a - 4:30p Compressed/Flexible: Not authorized Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Supervisory Position: No Bargaining Unit Position: Yes Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist/PD995860

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 11/11/2024. 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-11 position you must have served 52 weeks at the GS-9. 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. Specialized Experience Requirements at the GS-11 level: One year of specialized experience equivalent to the GS-9 level in Federal Service. To be creditable, your application package must demonstrate the following knowledge, skills and abilities: Knowledge of planning, coordination, and execution of business functions, resource allocation, and production. Identifies a need: gathers, organizes, and maintains information; determines its importance and accuracy, and communicates it by a variety of methods. Knowledge of procedures for assessing, evaluating, and monitoring programs or projects for compliance with Federal laws, regulations, and guidance. Understands and appropriately applies procedures, requirements, regulations, and policies related to specialized expertise OR, Education: Applicants may substitute for the required experience. To qualify based on education for this grade level you must have a 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 an combination of specialized experience and education beyond 1 year above a Master's Degree. Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. 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

A transcript must be submitted with your application if you are basing all or part of your 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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Central Virginia VA Health Care System 1201 Broad Rock Boulevard Richmond, VA 23249 US
• Name: Kelli Jackson
• Phone: (804) 675-5000
• Email: [email protected]