This position is in the VA, VHA, at the VA Medical Center (VAMC) in the Research and Development (R&D) Service. This position provides high level analytical and procedural support of projects in a comprehensive research setting.
To qualify for this position at the GS-11 grade level, you must have at least one (1) year of specialized experience directly related to this position. To be creditable, this experience must have been equivalent to at least the next lower grade level (GS-9) in the Federal Service that is directly related to the position. 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, 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. The experience required at this level is performed under general supervision, very difficult and responsible work along special technical or administrative lines in office, business, or fiscal administration requiring specialized training and considerable administrative experience which demonstrated capacity for sound independent work. Specialized experience also includes functioning as the Program Manager and Specialist for multiple regulatory committees, provide oversight of the entire review process of research protocols involving animal and/or human subjects, ensure that all 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), USDA, and Food and Drug Administration (FDA), develop and maintain required annual and semi-annual reviews of assigned programs, educate the investigative community of local and external policies and procedures about research involving animal and human subjects, develop programs, policies, and procedures with the Research Office, monitor quality assurance program implementation. -OR- You may substitute specialized experience with education if you have a Ph.D. or equivalent doctoral degree or three (3) full years of progressively higher-level graduate education leading to a Ph.D. This education must demonstrate the knowledge, skills, and abilities necessary to do the work. Examples: hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. A copy of your transcript(s) is required. -OR- Equivalent combinations of education and specialized experience (as described above) may also be used to meet the requirements. A copy of your transcript(s) is 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 IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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. 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; religious; 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. Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. The work is typically performed in an adequately lighted and climate-controlled office. May require occasional travel. 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*** This 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. This position may be assigned to one or more regulatory committees and functions under the direction of research leadership. R&D, IRB, IACUC, SRS, CIRB, IBC, and/or HRPP Program Administration 50% Serve as the Program Manager and Specialist for multiple regulatory committees Provide oversight of the entire review process of research protocols involving animal and/or human subjects Ensure that all 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), USDA, and Food and Drug Administration (FDA) Provide information to the respective regulatory research committees regarding ever-changing and evolving regulations Apply analytical and evaluative methods and techniques to research issues or studies and oversee and manage these programs and their activities Develop and maintain a pre-review program that coincides with IRB, IACUC, and R&D Committee review of all research involving human, animal subjects, basic laboratory science and the human research protection program Develop and maintain required annual and semi-annual reviews of assigned programs Provide review of ORD studies Educate the investigative community of local and external policies and procedures about research involving animal and human subjects Develop reporting procedures Quality and Compliance 25% Maintain the federal-wide assurance with the Office of Human Research Protection Maintain the IBC registration with the National Institutes of Health Office of Science Policy Maintain accreditation process for AAALAC Analyze and evaluate each research project to ensure compliance with Federal and State regulations Develop programs, policies, and procedures with the Research Office Monitor quality assurance program implementation Conduct quality improvement activities, special projects, or studies Administrative Oversight 25% Prepare all external reviews for FDA, USDA, ORO, AALAC, etc. Perform in-depth research and/or analyze problems, administrative issues, or program requirements about animal, human subjects or safety research Provide advice/consultation to IRB, IACUC, and R&DC chairs, members and staff on ethical principles, laws and regulations Design and studies training programs Serve as electronic records system administrator Work Schedule: Monday - Friday - 8:00AM - 4:30PM Recruitment & Relocation Incentives: Not authorized Telework: This position may be authorized for telework. AD-HOC - Telework eligibility will be discussed during the interview process.