The position is located in the Office of Research and Development (ORD), Veterans Health Administration (VHA), VA Central Office (VACO). ORD provides over $980 million in VA research funding to approximately 3500 VA scientists located in VA facilities across the United States. This vacancy may be filled in Washington, DC or a VA location to be determined.

Duties

The Regulatory Specialist (Biospecimens) will be responsible for serving as the ORD regulatory expert and consultant on policies, procedures, guidance, and FAQs related to biospecimens in VA conducted research studies. The position involves the policy and oversight of human biospecimens, including--but not limited to--blood and other body fluids, tissues, and other biological materials obtained from humans. Also responsible for policy related to subsets of human materials, such as derived cell lines that are traceable to a human subject or patients with linked identifiers or Personally Identifiable Information (PII) as well as those materials that cannot be linked to identifiers. The incumbent will provide education and training to the ORD staff, VA Medical Center Staff, investigators, and their study staff. The incumbent will serve an as expert consultant to the VA ORD funded biorepository programs. Work Schedule: Monday through Friday, 8:00 am to 4:30 pm Compressed/Flexible: Available Telework: Available (applicant is required on site 50% of work schedule per pay period) Remote: This is not a remote position. Virtual: The employee may work at a VA facility or other VA-leased space other than the facility that is hiring the employee and is authorized for telework up to 50%. Position Description/PD#: Health Science Specialist/PD423850 Relocation/Recruitment Incentives: Not authorized Critical Skills Incentive (CSI): Not approved Financial Disclosure Report: Not required

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 11/25/2024. 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-13 position you must have served 52 weeks at the GS 12. 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. All applicants MUST meet the following Individual Occupational Requirement and Specialized Experience in order to receive further consideration of their application. Individual Occupational Requirement You may qualify based on the required education as described below: Education You must possess a bachelor's or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) (https://www.opm.gov/leaving/index.aspx?link=http://ope.ed.gov/accreditation/) at the time the degree was obtained. Specialized Experience You may qualify based on your experience as described below: You must have one year of specialized experience equivalent to at least the next lower grade GS 12 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: 1) Providing program management in a research setting of a biospecimens program 2) Providing technical advice and guidance regarding biospecimens to managers and researchers 3) Developing policies, procedures, and criteria for administration of a biospecimens program 4) Providing education and training to staff and investigators on compliance with biospecimen policies and procedures 5) Evaluating compliance and auditing biospecimen facilities/collections in the setting of federal oversight visits 6) Employing expert knowledge in legal and ethical considerations related to biospecimen donation, collections, processing, handling, storage, inventory tracking, quality management practices, custodianship, disposal, sharing, release, and shipping in the performance of job duties 7) Performing analysis on technological and scientific developments in the biorepository field and providing authoritative information to policymakers. Note: Evidence of specialized experience must be supported by detailed documentation of duties performed in positions held on your resume. You must provide work experience information such as hours per week, salary, and starting/ending dates of employment (month and year format) to establish you have one (1) full year of Specialized Experience at or comparable to the required grade level. You will be rated on the following Competencies for this position: Audit ReportingComplianceStandardsStrategic ThinkingTeaching OthersTechnical Competence 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, including typical office work. The work does include travel to biospecimen handing facilities, meetings, and conferences. 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/.

Education

A transcript must be submitted with your application.

There is no educational substitution at this grade level.

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/.

Contacts

• Address VHA Central Office - Discovery, Education and Affliate Networks 810 Vermont Avenue NW Washington, DC 20420 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]