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.
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 policy. Designs, refines, and oversees tracking systems and databases used to manage the research program's full project portfolio, making improvement recommendations to leadership. Independently designs and implements quality assurance programs for the research committee structure, tailoring strategies to program culture and operational needs. Designs monitoring activities and measurable improvement plans, independently evaluating outcomes and implementing corrective measures without supervisory review. Designs and delivers training programs for committee chairs, members, and investigators on evolving federal and VA regulatory requirements, representing the facility in external regulatory/accreditation interactions. Leads investigation and analysis of adverse quality trends or serious/continuing non-compliance, determining root cause and directing corrective action across committees. 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. Tracks protocol review status from submission through continuing review and amendments, using established databases and systems, flagging delays to the supervisor as needed. Identifies routine compliance discrepancies in investigator submissions and communicates required corrections, escalating unresolved or disputed issues for guidance. 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: Monday-Friday, 8:00am - 4:30pm Telework: Ad-Hoc Telework authorized at the discretion of the supervisor. Virtual: This is not a virtual position. Position Description (PD) #: 99493-S, 99586-S Relocation/Recruitment Incentives: Not Authorized Financial Disclosure: Not required
Requirements
As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. You must be a U.S. Citizen to apply for this job Selective Service Registration is required for males born after 12/31/1959 Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. A pre-placement physical examination is not required. Subject to background/security investigation Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. As a condition of employment for accepting this position, you will be serving in a position in Schedule Policy/Career of the excepted service. You will obtain competitive status after two years of service in this position, if applicable. Effective May 7, 2025, driver's licenses or state-issued dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
Education
A transcript must be submitted with your application if you are meeting the Individual Occupational Requirement through 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.
How you will be evaluated
Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed 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 Your experience must be fully documented on your resume and must include job title, duties, month and year start/end dates AND hours worked per week. 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. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on the online assessment may also result in your removal from consideration. 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. During the application process you may have an option to opt-in to make your resume available to hiring managers in the agency who have similar positions. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions. Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities [i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities], and/or Disabled veterans with a compensable service-connected disability of 30% or more. Contact the Agency Contact for information on how to apply under this appointment authority via the Selective Placement Coordinator.