Research Protection Coordinator

Work Location: Wright Patterson AFB, OH/Remote

Cape Fox is seeking a highly qualified professional to join our team in support of a government customer. This position is contingent upon award.

Core Duties:

• Provide human subjects/animal use research protections technical review and administrative processing of research proposals, contracts, and other agreements with sufficient expertise that would enable them to independently provide critical guidance to program managers, contracting officers, researchers, and human/animal research protections officials regarding human subjects and animal use research administration, processing, standards, and regulations.
• Independently analyze/evaluate contract proposals, statements of work, and/or research proposals seeking Department of Defense funding/awards and coordinate/assist such efforts with investigators, IRBs, IACUCs, AF Human Research Protection Official (HRPO) in the 711 HPW/IR office, and its oversight organization at the Air Force Medical Readiness Agency (AFMRA) SGE-C, program managers, technical points of contact (TPOC), and Contracting Officers (CO) to guarantee efficient and timely human research protections compliance processing.
• Skillfully knowledgeable with federal and commercial IRB administrative requirements and apply knowledge of and discharge timely analysis of human subjects’ research related to a wide range of regulatory requirements including, but not limited to 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02_AFI 40-402; DODI 3216.01, AFI 40-401, DODI 6000.08, AFRLI 40-402, as well as Food and Drug Administration (FDA) regulations and policy related to drug and medical device research.
• Tasks require high degrees of proficiency in English writing and oral communication, allowing independent drafting e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
• Develop, plan, host, and deliver HRPP/IACUC training and education materials in various venues, web-site materials, workshops, training presentations, and quality assurance visits and discussions related to human research protections official administrative processing.
• Use prior knowledge, skill, training, and experience to independently use a desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems.
• Perform tasks within an electronic web-based system and will train customers on the use of such a system.
• Develop and maintain AFRL/RG human research and animal use protections compliance data bases and web-based systems for administrative management of tracking and documenting human research protections training of RG personnel, research proposal reviews, and TPOC human research HRPO approval coordination

Requirements:

• Experience working directly, in any capacity within a Human Research Protections Program (HRPP) and/or Institutional Animal Care and Use Committee (IACUC) program office, ideally within the Department of Defense (DoD). Such experience must have included the technical review and human/animal research protections compliance administrative processing of research proposals
• Familiar with HRPP/IACUC administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
• At least a Bachelor’s Degree or equivalent and preferably, but not required, meets technical and experience prerequisites to be qualified to test for HRPP/IACUC professional certifications.
• At least 1 year of current (within the past 3 years) or prior experience in reviewing research proposals for determinations of involvement of human subjects/animal research, or technical qualifications (through training, experience, or certification) to conduct such reviews, or specialized research program or administrative experience that would enable them to become capable of conducting such reviews.
• Prior experience in independently coordinating and drafting correspondence related to human/animal research protection official review and approval notices and other such technical correspondence for research protections officials, or other such specialized research or program management administrative experience that would enable contractor to learn and apply research protections specific requirements within one month.
• Prior experience in the development, planning, hosting, and delivering HRPP/IACUC training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to research protections compliance administrative processing and human subjects/animal use research technical and regulatory requirements.
• Knowledge, skill, training, experience, and ability to be highly proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems
• Have a signed Non-Disclosure Agreement (NDA) in place with their company based on the potential access to confidential, proprietary, and/or sensitive information. The NDA shall be provided to the Government Program Manager by start of performance
• Must be able to pass a Tier 1 Background Investigation

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