Research Protection Specialist

2 hours ago

Menasha, Wisconsin, United States Cape Fox Federal Contracting Group Full time
Job Title: Research Protection Coordinator

Cape Fox Federal Contracting Group is seeking a highly qualified professional to support our government customer.

This position is contingent upon award.

The United States Air Force Small Business Innovation Research (SBIR) program is headquartered in Dayton, Ohio, and is part of the Air Force Research Laboratory (AFRL) RG Technical Directorate. The SBIR program solicits domestic small businesses to engage in Federal research and development with the possibility of commercialization.

Key Responsibilities:
  • Provide technical review and administrative processing of research proposals, contracts, and other agreements with sufficient expertise to independently provide critical guidance to program managers, contracting officers, researchers, and human research protections officials regarding human subjects research administration, processing, standards, and regulations.
  • Analyze and evaluate contract proposals, statements of work, and/or research proposals seeking Department of Defense funding/awards and coordinate/assist such efforts with investigators, IRBs, AF Human Research Protection Official (HRPO) to guarantee efficient and timely human research protections compliance processing.
  • Experience with federal and commercial IRB administrative requirements. 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; HHS 45 CFR 46; DoD 32 CFR; DoDI.02_AFI 40-; DODI.01, AFRLI 40-, as well as Food and Drug Administration (FDA) regulations and policy related to drug and medical device research.
  • Develop, plan, host, and deliver HRPP 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.
  • Experience to utilize a desktop computer workstation for accomplishment of tasks in Microsoft Office, as well as internet applications.
  • Develop and maintain a human research protections compliance data bases and web-based systems for administrative management of tracking and documenting human research protections training, research proposal reviews, and human research HRPO approval coordination.
Requirements:
  • Experience working directly, in any capacity within a Human Research Protections Program (HRPP) office, ideally within the Department of Defense (DoD). Such experience must have included the technical review and human research protections compliance administrative processing of research proposals.
  • Familiar with HRPP administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
  • A Bachelor's Degree in any discipline and qualified to test for HRPP professional certification.
  • One year of current (within the past 3 years) or prior experience in reviewing research proposals for determinations of involvement of human subject's research, or technical qualifications (through training, experience, or certification) to conduct such reviews, or specialized research program or administrative experience that would enable contractor to become capable of conducting such reviews.
  • Experience in independently coordinating and drafting correspondence related to human research protection official review and approval 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.
  • Experience in the development, planning, hosting, and delivering HRPP training and education materials, including web-site materials, workshops, training presentations, and quality assurance visits and discussions related to research protections compliance administrative processing and human subjects research technical and regulatory requirements.
  • Experience and ability to be highly proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Office as well as internet page maintenance, and cloud-based/web-based research protocol management systems.
  • Tier 1 background investigation is required.
  • Must have authorization to work in the United States as defined by the Immigration Reform Act of.

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