DESCRIPTION OF WORK
The 711 HPW is the leader of Line of the Air Force and Defense Health Program human research efforts. The 711 HPW/Institutional Review (IR) is responsible for administering the Human Research Protection Program (HRPP). It provides regulatory compliance oversight, IRB review, and training and education to human use researchers for a wide-range of human performance non-clinical and clinical research, in support of the AFRL mission and AF-wide customers. The USAF School of Aerospace Medicine (an organization within the 711 HPW and AFRL) provides Aerospace Medicine Training, Education, and Consultation to enhance Warfighter Performance and Combat Casualty Care for World Wide Operations in Garrison and War. It is the center for aeromedical education, training, and consultation in direct support of hyperbaric, human performance, clinical and environmental health, expeditionary medical support, and aeromedical evacuation, in support of the USAFSAM mission.
DESCRIPTION OF EDUCATION AND EXPERIENCE REQUIRED
- Relevant Institutional Review Board (IRB) experience
- Previous experience working for the U.S. government/military highly desirable . This will be verified from prior employment,
- Documented success in no less than two substantive years of previous IRB administrative processing and related HRPP exposure.
- Have practical knowledge of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel as well as database design and management, internet applications including e-mail, world-wide web searches and web-page maintenance.
DESCRIPTION OF CERTIFICATIONS REQUIRED
- Collaborative Institutional Training Initiative (CITI) training certification.
DESCRIPTION OF TASKS
The candidate shall...
- Provide critical guidance to investigators, management and command regarding human subjects research administration, standards and regulations.
- Analyzes/evaluates human research protocols and coordinates/assists investigators' efforts to guarantee efficient and timely processing of protocols and regulatory compliance and shall conduct quality assurance audits of 711 HPW/IR customers to confirm such regulatory compliance.
- Document levels of education, training and relevant IRB experience in order to discharge human subjects; per research-related regulatory requirements.
- Draft e-mail and official correspondence as needed to facilitate the administrative and regulatory life-span of all Defense Health Program and will have prior experience in the drafting of such correspondence.
- Have relevant knowledge or experience in medical operations administration and/or clinical research science administration.
- Assist in the development, processing and maintenance of all aspects of human use protocol packages by the USAFSAM and other human use research customers of 711 HPW/IR.
- Provide timely and technical review and recommendations aimed at preserving the safety of human subjects in research and maintain the efficient and timely processing of research protocols.
- Develop, 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.
- Analyze and maintain 711 HPW/IR databases for administrative management of research protocols, protocol related documentation/information management, and research protocol matrix for protocol processing and time management.