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Research Protection Coordinator (FOPR 22-97 RG Regulatory Protection Support)
Anywhere, USA · Government/MilitaryHuman & Animal Research Protection Coordinator (FOPR 22-97 RG Regulatory Protection Support)
INTRODUCTION:
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.
Mandatory Qualifications:
Duties and Responsibilities:
Employee must be a U.S. citizen. For the purpose of base and network access, possession of a permanent resident card (“Green Card”) does not equate to U.S. citizenship.
Work Schedule:
Work schedule is normally 7:30 a.m. to 4:30 p.m., Monday through Friday, however, there may be times when it is necessary for the contractor to work after duty hours or weekends in support of specific taskings. There may be times where the hours may be flexible depending on fluctuating workload volume. Although schedule may be flexible, it will not exceed 40 hours per week
Work Location:
Work may be accomplished via standard in office or telework format.
Travel:
Contractor travel is not envisioned under this effort. If deemed applicable, such travel will only be as directed and coordinated through the COR two weeks in advance of all contractor travel in order to obtain proper authorizations.
Point of Contact for this Opportunity:
Art Mata
amata@reef-sys.com
INTRODUCTION:
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.
Mandatory Qualifications:
- Contractor shall have 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.
- Contractor shall be familiar with HRPP/IACUC administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
- Contractor shall have 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.
- Contractor shall have 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 contractor to become capable of conducting such reviews.
- Contractor shall have 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.
- Contractor shall have 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.
- Contractor shall have 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.
Duties and Responsibilities:
- Contractor shall 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 the contractor 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.
- Contractor shall 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.
- Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be skillfully knowledgeable with federal and commercial IRB administrative requirements. Tasks shall be of a specialized variety and Contractor shall independently 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. These capabilities, obtained through higher educational academics or experience, shall enable the Contractor to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
- Contractor shall be qualified to 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.
- Contractor shall use prior knowledge, skill, training, 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. The Contractor shall perform tasks within an electronic web-based system and will train customers on the use of such a system.
- Contractor shall 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.
Employee must be a U.S. citizen. For the purpose of base and network access, possession of a permanent resident card (“Green Card”) does not equate to U.S. citizenship.
Work Schedule:
Work schedule is normally 7:30 a.m. to 4:30 p.m., Monday through Friday, however, there may be times when it is necessary for the contractor to work after duty hours or weekends in support of specific taskings. There may be times where the hours may be flexible depending on fluctuating workload volume. Although schedule may be flexible, it will not exceed 40 hours per week
Work Location:
Work may be accomplished via standard in office or telework format.
Travel:
Contractor travel is not envisioned under this effort. If deemed applicable, such travel will only be as directed and coordinated through the COR two weeks in advance of all contractor travel in order to obtain proper authorizations.
Point of Contact for this Opportunity:
Art Mata
amata@reef-sys.com