Health System Specialist - Research Committee Manager

To qualify for this position at the GS-11 grade level, you must meet one of the following: Experience: You must have at least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-9) in the Federal Service that has given you the particular knowledge, skills, and abilities required to successfully perform the duties of a Health System Specialist - Research Committee Manager, and that is typically in or related to the work of the position to be filled and provided you with knowledge of the full scope of activities required to conduct single and multisite research in the areas of human subject protection, biosafety, Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), and Research and Development (R&D) Committees through regulatory and policy compliance.

Specialized experience is defined as progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field. This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities.

Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities and provided knowledge of the following: 1) Missions, organizations, programs, and requirements of health care delivery systems; 2) Regulations and standards of various regulatory and credentialing groups; and 3) Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement; and knowledge of cognitive engineering, human factors engineering, human-computer interaction, or related fields.

NOTE: Experience must be fully documented on your resume and must include job title, duties, month and year start/end dates AND hours worked per week. ~OR~ Education: Successful completion of a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree in a major study such as hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration.

Such education must demonstrate the knowledge, skills, and abilities necessary to do the work of the Health System Specialist - Research Committee Manager position. NOTE: Transcripts (unofficial or official) must be submitted with your application materials.

Education cannot be credited without documentation. ~OR~ Combination: Equivalent combination of successfully completed graduate level education (beyond the second year) and specialized experience, as described above, which may be used to meet total experience requirements for this grade level.

The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do the work of the Health System Specialist - Research Committee Manager position such as hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. NOTE: Transcripts (unofficial or official) must be submitted with your application materials. Education cannot be credited without documentation.

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/.

THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION The Research Committee Manager position is vital within the ORD and the facilities where research programs are conducted. Research Program Managers provide the link between Veterans and highly innovative projects.

The major duties include but are not limited to: Research and Development (R&D), Institutional Review Board (IRB), Institutional Animal Care and Use Committees (IACUC), Subcommittee for Research Safety (SRS), Central Institutional Review Board (CIRB), Institutional Biosafety Committee (IBC), and/or Human Research Protection Program (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; Serves as the accreditation Facility Liaison; 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; Stays informed on guidelines relating to security and safety in the conduct of research and advises Research and Safety leadership, as needed; 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 Maintains the federal-wide assurance with the Office of Human Research Protection and ensures IRBs are appropriately constituted and registered; Maintains the IBC registration with the National Institutes of Health Office of Science Policy and ensures IBC is appropriately constituted and registered; Maintains 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, Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), Office of Research Oversight (ORO), and other applicable regulatory and procedural requirements; Develops programs, policies, and procedures within the Research Office; 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; Alerts investigators of deficiencies found within their submissions and educates them as to the steps required to correct the deficiencies; Administrative Oversight Assumes responsibility in preparing for all external reviews; Researches 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; Oversees and refines customized, networked computerized databases to allow for timely tracking of research projects; Serves as the electronic records system administrator for the Research Office; and, Performs all other duties as assigned.

Work Schedule: Monday through Friday, 8:00am to 4:30pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process.