HRPP professional certification or qualification to obtain such certification is preferred.
Provide 711 HPW/IR management and administrative support and assistance necessary to aid HRPP oversight and compliance and IRB review, primarily for Science and Technology human research and other human research as needed.
Shall provide critical guidance to investigators, management and command regarding human subject’s research administration, standards and regulations.
Analyzes research protocols and coordinates/assists investigators’ efforts to guarantee efficient and timely processing of protocols and regulatory compliance. Shall conduct quality assurance audits of 711 HPW/IR customers to confirm such regulatory compliance.
Shall be familiar with AF IRB approval process and have basic knowledge of and ability to apply human subjects research related regulatory requirements including 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02_AFI 40-402; DODI 6000.08, AFRLI 40-402, as well as Food and Drug Administration (FDA) regulations and policy related to drug and device research.
Shall draft e-mail and official correspondence as needed to facilitate the administrative and regulatory life-span of all Science and Technology program funded human subject research and other human subject research as needed for 711 HPW/IR and will have prior experience in the drafting of such correspondence.
Shall assist in the development, processing and maintenance of all aspects of human use protocol packages by the Airman Systems Directorate and other human use research customers of 711 HPW/IR. Shall provide timely technical reviews and recommendations aimed at securing safety of human subjects in research, following regulatory compliance, and providing efficient and timely processing of research protocols.
Shall design, plan, host and deliver training and education materials, including; organizational web-site materials, workshops, training presentations, and quality assurance visits and discussions related to IRB administrative processing and HRPP for 711 HPW/IR human use research customers.
Shall analyze and maintain 711 HPW/IR databases and web-based systems for administrative management of research protocols, protocol related documentation/information management, and research protocol matrix for protocol processing and time management.
Shall interface with the following staff offices: 711th Human Performance Wing (HPW) (USAFSAM, RH, and HP), USAF Surgeon General Research Compliance (SGE- C), and other contractors and research collaborators in order to administratively process human use research protocols and programs.
Experience & Knowledge
Minimum of five years experience
Shall have either previous experience working for the U.S. government/military or at least two years previous experience working directly with AF HRPP and IRB related administrative matters.
Education & Certification
All personnel shall undergo a National Agency Check with Local Agency Check and Credit Check (NAC/LC) background check.
Lukos provides professional staffing services to the Department of Defense, other government agencies, and the national security industry. Lukos brings recent and relevant operational and management experience at the cutting edge of special operations. Lukos is a Small Business Administration certified 8(a) Small Disadvantaged Business and a Veterans Administration certified Service Disabled Veteran Owned Small Business.