- Provide human subjects use research protections 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.
- 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.
- Have knowledge and understanding of the following regulatory requirements including but not limited to: 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI _AFI 40-402; DODI , AFRLI 40-02, as well as Food and Drug Administration (FDA) regulations and policy related to drug and medical device research.
- High degrees of proficiency in English writing and oral communication to show ability to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
- 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.
- Perform tasks within an electronic web-based system and will train customers on the use of such a system.
- 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.
- Some travel may be required as needed.
- Other duties as assigned.
- Bachelor's degree in any discipline.
- Qualifying prerequisites to test for HRPP professional certification.
- 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 technical review and human research protections compliance administrative processing of research proposals.
- Familiarity with HRPP administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance.
- At least one (1) year of current (within the last 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 show capability of conducting such reviews.
- 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 specialized research or program management administrative experience that would show capability to learn and apply research protections specific requirements within one month.
- Prior experience in the development, planning, hosting and delivering HRPP training and educational 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 subject research technical and regulatory requirements.
- Must 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.
- Must be willing to sign a Non-Disclosure Agreement (NDA).
- Preferred knowledge and experience in Federal and Commercial IRB administrative requirements.
- Must be a U.S. Citizen
- Must pass a Tier 1 background check.
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Research Protection Coordinator - Dayton, United States - Alakaina Family of Companies
Description
The Alaka`ina Foundation Family of Companies (FOCs) has a potential need for a Research Protection Coordinator to support the 711th Human Performance Wing (HPW) located at Wright-Patterson Air Force Base (AFB) in Dayton, OH.
This opportunity will be 100% REMOTE.DESCRIPTION OF RESPONSIBILITIES:
REQUIRED DEGREE/EDUCATION/CERTIFICATION:
REQUIRED SKILLS AND EXPERIENCE:
REQUIRED CITIZENSHIP AND CLEARANCE:
Eligible full-time employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
We are an Equal Opportunity/Affirmative Action Employer.We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation.
We E-Verify all employees.
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses.
The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kāpili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC.
Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
For additional information, please visit#LI-JS1
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