The position is in the VA, VHA, at a VA Medical Center (VAMC) in the Research and Development (R&D) Service. The position is fully responsible 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.

Duties

Promotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met. Selection at a lower grade level does not guarantee promotion to the full performance level. The position 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. The position requires 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 R&D Committees through regulatory and policy compliance. Research involves issues that are of high risk and high visibility and directly impact the reputation of VA's research program, both regionally and nationally. The position is directly involved in the approval of research and must be able to interpret, analyze and use discretion to implement and devise a wide range of research policies. The 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. The incumbent will be responsible for a broad array of duties, including the oversight of the entire review process of research protocols involving animal and/or human subjects. The review process encompasses all research committees reviewing animal and human research, e.g., the R&D Committee, both in-house and external IRBs, Subcommittee for Research Safety (SRS), the Institutional Biosafety Committee (IBC), IACUC, the Human Research Protection Program (HRPP), the Animal Care and Use Program (ACUP) and the Research Safety and Security Program (RSSP). 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 (AAALAC), 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. Work Schedule: Monday - Friday 8:00am - 4:30pm Telework: Telework eligibility will be discussed during the interview process. Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist/PD99493-S Financial Disclosure Report: Not required Physical Requirements: Work is typically performed in an adequately lighted and climate-controlled office. May require occasional travel.

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 08/30/2023. Individual Occupational Requirements: The 0671 series requires specific education or experience to be met in order to be appointed into a position of this series. You must meet one of the pre-determined Education or Experience Individual Occupational Requirements listed below as set by Office of Personnel Management (OPM). Undergraduate and Graduate Education: Major study -- hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. OR, Specialized Experience: 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: 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. OR., Special Provision for In-service Placement: Successful completion of an agency-sponsored on-the-job training program may be substituted for qualifying experience, provided 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. 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. These applicants must have held the GS-07 grade or higher for a year in order to meet this requirement for the GS-09 level of this vacancy. These applicants must have held the GS-09 grade or higher for a year in order to meet this requirement for the GS-11 level of this vacancy. 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. In addition to meeting the IOR listed above, an applicant must also meet the minimum qualifications listed below: GS-09 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: and abilities to successfully perform the duties of a Health System Specialist - Examples of creditable specialized experience in a minimum of 3 of the following: Adherence to designated policies and procedures; ability to coordinate activities with other programs, to include review and evaluation of operations, policies, and procedures; ability to develop reports, studies, business plans, and presentations for leadership; Ability to design work processes and systems that are responsive to customer needs. (This experience must be well documented in your resume or application package.)] 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, three (3) full years of progressively higher-level graduate education leading to such a degree, or LL master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. The education portion must include courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. GS-11 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: and abilities to successfully perform the duties of a Health System Specialist - Research Committee Manager 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 R&D Committees through regulatory and policy compliance. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-9) in the normal line of progression for the occupation in the organization. Specialized experience includes 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.. 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, three (3) full years of progressively higher-level graduate education leading to such a degree, or LL.M. in the related field of the position to be filled (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). The education portion must include courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. Education must have been obtained in an accredited college, or university. 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 . You will be rated on the following Competencies for this position: Administration and ManagementCritical ThinkingProject ManagementResearch

Education

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.


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/.

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.

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 San Francisco VA Medical Center 4150 Clement Street San Francisco, CA 94121 US
• Name: Diana Avila-Linaja
• Phone: 650-694-6000 X15130
• Email: [email protected]