Major Duties:
- Serves as a key subject-matter expert supporting animal, basic science, and human research activities, including clinical trials involving investigational drugs, devices, and procedures.
- Oversees the full review process for research protocols involving animal and/or human subjects to ensure timely and compliant review, approval, and follow-up.
- Provides primary training for new committee members on relevant policies, procedures, and responsibilities associated with their regulatory roles.
- Communicates regulatory updates and evolving requirements to research committees, ensuring members remain informed of changes impacting human and animal research.
- Conducts comprehensive reviews of local investigator studies as part of institutional quality assurance processes.
- Applies analytical and evaluative methods to assess research program operations, identifies process issues, and implements improvements to enhance committee or board effectiveness.
- Resolves compliance concerns by providing guidance, support, and negotiated solutions when committee recommendations or determinations are disputed by investigators or coordinators.
- Oversees and manages program activities, including preparing committee materials, coordinating reviewer documentation, ensuring proper personnel involvement, and resolving outstanding project-related issues.
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.
Work Schedule: Full-time, 8-hour shifts Monday through Friday, with tours scheduled between 7:30am-4:30pm.
Telework: This position may be authorized for Ad-hoc telework. Ad-hoc telework eligibility will be discussed during the interview process.
Virtual: This is not a virtual position.
Return to Office (RTO): RTO mandates are in effect and selectees will be required to report to in-person work unless they are approved for an exception or an exemption. Any approval for an RTO exception, exemption, or extension will happen after a tentative job offer, but before a final job offer.
Position Description/PD#: Health System Specialist/PD99586S and PD99493S
Relocation/Recruitment Incentives: Not Authorized
Critical Skills Incentive (CSI): Not Approved
Physical Requirements: The work required does not inherently include any physical requirements essential for successful job performance that could not otherwise be performed with accommodation or workplace adjustment. A pre-placement physical examination is not required.
THIS POSITION HAS THE FOLLOWING INDIVIDUAL OCCUPATIONAL REQUIREMENT:
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 (FOR POSITIONS ABOVE GS-5): 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.
SPECIAL PROVISION FOR INSERVICE 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.