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***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION***

Duties include, but may not be limited to the following:

Research & Development (R&D), Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), Subcommittee for Research Safety (SRS), Central Institutional Review Board (CIRB), Institutional Biosafety Committee (IBC), and/orHuman 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.
• Carries 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, developing and managing the post approval monitoring program for assigned committees.
• Stays informed on guidelines relating to human subject protection in research and advises Research and IRB leadership.
• Serves as a member of the HRPP working group.
• Ensures that human subject research is reviewed, approved, and conducted in accordance with appropriate Federal, State and VA regulations and guidelines, funding agency specific guidelines, institutional policies, and appropriate accreditation standards.

• Maintains the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered.
• Maintains 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, Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), Office of Research Oversight (ORO), and other applicable regulatory and procedural requirements.

• Assumes responsibility in preparing for all external reviews such as: Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Office of Research Oversight (ORO), National Health Institutes Office of Science Policy (NIH OSP), American Association for Accreditation of Laboratory Animal Care (AAALAC), Office for Human Research Protections (OHRP), and Office of Laboratory Animal Welfare (OLAW), which includes securing all necessary documents and demonstrating practices to reflect full compliance.
• Examines and/or analyzes problems, administrative issues, or program requirements as they relate to animal, human subject or safety research and the research review process.
• Performs in-depth research, analyzes operating contingencies and special situations, and applies standard analytical techniques.
• Performs analysis of stable work processes to identify reasonable and efficient quality measurements tailored to the activity.
• 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.

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
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
• Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.

Qualifications

To qualify for this position, you MUST meet the following requirements:

Undergraduate and Graduate Education:
Having completion of one (1) full year of education, such as education must demonstrate the knowledge skills and ability required to do the work of the position. (i.e., having a major study in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration.). The Education must have been at the graduate level and been obtained in an accredited college or university and must demonstrate the knowledge, skills ability necessary to do the work of this position. Note: Transcripts must be submitted with your application materials. You cannot receive Education credit without the transcripts. (Transcript Required)
or
SPECIALIZED EXPERIENCE GS-11: Having one (1) year of specialized experience that equipped them with the knowledge, skill, and abilities to successfully perform the duties of the Health System Specialist position, and that is in or related to the work of this position. To be creditable, this experience must have been equivalent to at least the GS-9 level in the Federal service. Specialized experience is 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: (a) Missions, organizations, programs, and requirements of health care delivery systems; (b) Regulations and standards of various regulatory and credentialing groups; (c) 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.
OR
SUBSTITUTION OF EDUCATION FOR EXPERIENCE GS-11:
Applicants must have a Ph.D. or equivalent doctoral degree or three (3 ) full years of progressively higher level graduate education leading to such a degree or LL.M., if related. This education must demonstrate the knowledge, skills, and abilities necessary to do the work of this position. (Transcript Required)
OR
COMBINING EDUCATION AND EXPERIENCE GS-11: - Combination of successfully completed graduate education and experience may be used to meet total qualification requirements. (Transcript Required)


You will be rated on the following Competencies as part of the assessment questionnaire for this position:

• Administration and Management
• Critical Thinking
• Project Management
• 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. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).

Your responses to the assessment questionnaire will be reviewed along with the information provided in your resume and supporting documentation to determine if you are qualified for the position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your rating may be lowered and/or you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

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.

Candidates who apply under All U.S. Citizens announcements will be rated and ranked using Category Rating procedures. Qualified candidates will be assigned to a quality category. The categories are defined as follows:

• Best qualified - applicants possessing experience that substantially exceeds the minimum qualifications of the position including all selective factors, and who are highly proficient in all requirements of the job and can perform effectively in the position;
• Highly qualified - applicants possessing experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the requirements of the job;
• Well qualified - applicants possessing experience that meets the minimum qualifications of the position including all selective factors, and who are proficient in some, but not all, of the requirements of the job; and
• Qualified - applicants possessing experience and/or education that meets the minimum qualifications of the position including all selective factors.