Health System Specialist

Summary This position is in the Ann Arbor VA Medical Center - Ann Arbor - MI - 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-to-day support for the VA Research Program. Qualifications To qualify for this position - applicants must meet all requirements by the closing date of this announcement - 11/03/2026. 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. All applicants MUST meet the following Individual Occupational Requirements: 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. 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. In addition to the Individual Occupational Requirements - you MUST also meet the specialized experience requirements. GS-09 Grade Level: GS-9 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: Applies working knowledge of core regulatory frameworks (21 CFR Parts 11/50/56 - 45 CFR Part 46 - HIPAA Privacy Rule - applicable VHA Handbooks) to routine protocol review and committee support tasks. Under general supervision - analyzes research project submissions for compliance with Federal and VA regulations (FDA - OHRP - ORO - USDA - OLAW - AAALAC) - referring novel or precedent-setting compliance questions to the supervisor. Assists in maintaining required federal-wide assurances and program registrations (e.g. - OHRP Federalwide Assurance - IBC/NIH OSP registration) - verifying committee rosters and documentation are current. GS-11 Grade Level: 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: Serves as the institutional subject-matter expert and point of contact for regulatory frameworks (21 CFR Parts 11/50/56 - 45 CFR Part 46 - HIPAA Privacy Rule - VHA Handbooks) - advising R&D leadership directly. Independently analyzes and evaluates research projects for compliance with Federal and VA regulations (FDA - OHRP - ORO - USDA - OLAW - AAALAC) across multiple concurrent committees - resolving ambiguous or novel compliance questions without referral. Serves as the institutional owner of required federal-wide assurances and program registrations - ensuring continuous compliance and representing the facility during external accreditation and regulatory reviews. Independently develops and manages the full review calendar across multiple regulatory committees (R&D - IRB - IACUC - IBC - SRS) - setting deadlines and resolving scheduling conflicts without supervisory involvement. Owns the end-to-end protocol review lifecycle across the research portfolio - proactively resolving bottlenecks and process breakdowns affecting multiple stakeholders. Independently identifies and remediates compliance issues through intercession with investigators - negotiating resolutions on disputed committee recommendations. Independently resolves complex or first-time technical questions from investigators - committee chairs - and external regulatory bodies on human subject protection - animal care - or biosafety policy. You will be rated on the following Competencies for this position: Attention to Detail Customer Service Decision Making Flexibility Integrity/Honesty Interpersonal Skills Learning Reading Comprehension Reasoning Self-Management Stress Tolerance Teamwork 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. 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. Physical Requirements: The work is primarily sedentary - although some slight physical effort may be required. For more information on these qualification standards - please visit the United States Office of Personnel Management's website at http://://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/. Duties Duties include but are not limited to: Independently resolves complex or first-time technical questions from investigators - committee chairs - and external regulatory bodies on human subject protection - animal care - or biosafety policyDesigns - refines - and oversees tracking systems and databases used to manage the research program's full project portfolio - making improvement recommendations to leadershipIndependently designs and implements quality assurance programs for the research committee structure - tailoring strategies to program culture and operational needsDesigns monitoring activities and measurable improvement plans - independently evaluating outcomes and implementing corrective measures without supervisory reviewDesigns and delivers training programs for committee chairs - members - and investigators on evolving federal and VA regulatory requirements - representing the facility in external regulatory/accreditation interactionsLeads investigation and analysis of adverse quality trends or serious/continuing non-compliance - determining root cause and directing corrective action across committeesApplies working knowledge of core regulatory frameworks (21 CFR Parts 11/50/56 - 45 CFR Part 46 - HIPAA Privacy Rule - applicable VHA Handbooks) to routine protocol review and committee support tasksTracks protocol review status from submission through continuing review and amendments - using established databases and systems - flagging delays to the supervisor as neededIdentifies routine compliance discrepancies in investigator submissions and communicates required corrections - escalating unresolved or disputed issues for guidancePromotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory - qualification - and performance requirements are metSelection at a lower grade level does not guarantee promotion to the full performance levelWork Schedule: Monday-Friday - 8:00am - 4:30pm Telework: Ad-Hoc Telework authorized at the discretion of the supervisorVirtual: This is not a virtual positionPosition Description (PD) #: 99493-S - 99586-S Relocation/Recruitment Incentives: Not Authorized Financial Disclosure: Not required