- Contractor shall have 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.
- Contractor shall be familiar with HRPP administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
- Contractor shall have a Bachelor's Degree in any discipline and experience prerequisites to be qualified to test for HRPP professional certification.
- 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 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 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 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 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.
- Contractor shall provide human subjects 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 research protections officials regarding human subjects research administration, processing, standards and regulations.
- Contractor shall work within the 711 HPW/IR office and will 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, 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 _AFI 40-402; DODI , 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 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 711 HPW/IR 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.
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Research Protection Coordinator - Dayton, United States - Advent Services LLC
Description
**Recruiters please do NOT contact Advent Services**A leader in supporting clients in technically demanding industries, Advent's capabilities and services promote innovation & empower our partners to manage risk, protect the information, and achieve organizational objectives. We are proud of our ability to support mission-critical systems in every phase of their lifecycle to ensure our nation's forces can accomplish their mission.
Position: Research Protection Coordinator
Location: Remote
Schedule: Work schedule is normally M-F however, there may be times when it is necessary for the contractor to work after duty hours in support of specific tasks. Although schedule may have to be flexible, it will not exceed 40 hours per week.
Position Description:
The scope of this effort is to direct, develop, and manage multiple complex data tracking mechanisms to provide accurate accountability of educational resources and utilization metric to include (student data, allocation utilization, learning management system analysis, and other analytical duties required to accomplish mission priorities). Data generated will support the strategic vision of the USAFSAM Education and Training mission, the Aerospace and Operational Medical Enterprise (AOME) teams at DoD installations worldwide, higher headquarters personnel, and supported line mission partners.
Mandatory Qualifications:
Advent is an Equal Opportunity Employer. Employment decisions are not based on race, color, religion, sex, national origin, disability status, genetics, protected veteran status, or any other characteristic protected by federal, state or local laws.
