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Duties and responsibilities include, but are not limited to:

• Fully responsible to manage regulatory committees and provide subject matter expertise regarding the underlying regulations in ensuring compliance in research.
• Provides high level analytical and procedural support of projects in a comprehensive research setting, providing day-to­day support for the VA Research Program.
• Works independently, in conformance with established practices and prescribed procedures and makes recommendation to update established practices and procedures when indicated.
• Provides a high level of analytical and procedural skill to perform a variety of complex tasks related to the approval and maintenance of research projects including necessary regulatory approvals, decisions, submissions that are tied to protocol execution, data reporting and management.
• Primary responsibilities of the incumbent are to serve as the Program Manager and Specialist for multiple regulatory committees. The incumbent serves as an expert and key player in activities related to animal, basic science and human research including clinical trials of investigative drugs, devices, and methods.
• Ensures that all the respective committee actions and procedures are within the scope of all applicable local, Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of Laboratory Animal Welfare (OLAW), Office of Safety and Health Administration (OSHA), United States Department of Agriculture (USDA), and Food and Drug Administration (FDA) regulations.
• Provides information to the respective regulatory research committees regarding the ever-changing and evolving regulations, as well as noteworthy news items pertaining to medical research including but not limited to human studies.
• Oversees and manages 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, e.g., Association for the Assessment and Accreditation for Laboratory Animal Care International (MALAC), human accreditation, etc., and is responsible for the preparation of accreditation applications, maintenance of standard operating procedures in accordance with accreditation agency standards, maintenance of institutional forms in accordance with accreditation agency standards, and maintenance of committee operations in accordance with accreditation agency standards.
• 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. Serves in an advisory capacity to committee members and committee support staff and provides education and guidance on applicable policies and procedures.
• 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.
• 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.
• Conducts quality improvement activities, special projects, or studies. Investigates and analyzes adverse quality trends or conditions. Reviews and submits documentation of quality improvement activities.

Conditions of employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• You may be required to serve a probationary period
• 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)

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 04/25/2025.

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-09 position you must have served 52 weeks at the GS-07. For a GS-11 position you must have served 52 weeks at the GS-09. 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. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment.

You may qualify based on your experience and/or education as described below:

The Occupational Series 0671 includes an Individual Occupational Requirement (IOR). Candidates may not hold a position in this series without meeting one of the IOR requirements established by OPM.

• Undergraduate or graduate education in a major field of study hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration.

• Specialized experience in Missions, organizations, programs, and requirements of health care delivery systems; Regulations and standards of various regulatory and credentialing groups; and Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement.

• Successful completion of an agency-sponsored on-the-job training program, it included a formal individualized training plan. Such a training program must have been conducted in an operating health care system and included: ? Assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; ? Practical assignments providing an opportunity to apply health system administration skills and principles (as the individual progresses, work assignments must be characteristic of the grade level to which he or she is assigned); and oversight by an experienced health system administrator with periodic evaluation of the individual's progress and appropriate adjustment of the training program.

• In addition to meeting the IOR, you may qualify based on your specialized experience as described below:

• Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-07 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Skill in applying analytical and evaluative techniques to the identification, consideration, and resolution of issues or problems of a procedural or factual nature in applying Federal, State and VA laws, rules, and regulations relative to compliance and the conduct of investigative studies involving human subjects, animal study research, research safety and security, and research information security; including but not limited to the US Food and Drug Administration, Department of Agriculture, Department of Health and Human Services, Office for Human Resource Protections, Office of Research Oversight, Association for Assessment and Accreditation of Laboratory Animal Care International, Office Laboratory Animal Welfare, Public Health Service, Drug Enforcement Agency and current accreditation agencies. OR,
• Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have Master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. 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 18 semester hours in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration.

• Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-09 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Manage regulatory committees and provide subject matter expertise regarding the underlying regulations in ensuring compliance in research. The position provides high level analytical and procedural support of projects in a comprehensive research setting, providing day-to­day support for the VA Research Program. OR,
• Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have successfully completed a Ph.D. or equivalent doctoral degree or completed 3 progressively higher level graduate education leading to such a degree in a major study of hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration or superior academic achievement. OR,
• Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education at the Ph.D level or equivalent doctoral degree.

• Administration and Management
• Quality Assurance
• Research

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE.

Narrative responses are not required at this time. If you are referred for consideration, you may be asked to submit additional job related information, which may include, but not limited to; responses to the knowledge, skills and abilities; completion of a work sample, and/or contact for an interview. Your resume and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect your rating or consideration for employment.

The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.

For more information on the "Who may apply" eligibility requirements, please refer to the OHRM Status Candidates and Other Candidate Definitions document.

Placement Policy: The posting of this announcement does not obligate management to fill a vacancy or vacancies by promotion. The position may be filled by reassignment, change to lower grade, transfer, appointment, or reinstatement. Management may use any one or any combination of these methods to fill the position.

It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.

Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.