Institutional Review Board Analyst Telework

Institutional Review Board Analyst - Telework

Location
Human Research Protection Program
Air Force Research Laboratory
U.S. Air Force Small Business Innovation Research
Wright- Patterson AFB OH 45433-7913

• Citizenship: U.S. Citizenship and DoD Security Clearance Required.
• Clearance Requirements: Tier 1 Background Investigation - National Agency Check with Law and Credit Check and fingerprints. (Standard Form 85).
• Type of Employment: 40 hours per week.
• Period of Performance: 30 September 2024 29 May 2027
• Estimated Pay: $75,000.00 $80,000.00 Based on Experience
• Travel: Travel is required with this position.

Summary of Services:

The Institutional Review Board (IRB) Analyst will be crucial in the U.S. Air Force Small Business Innovation Research program by providing support by assisting in reviewing and administrative processing 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 in general, as well as specific to the bio-technology domain.

Working Hours

The Institutional Review Board Analyst working hours will be from 0730 to 1630, Monday through Friday, except Federal holidays, unless the Contracting Officer Representative stipulates otherwise. Although the schedule may have to be flexible, it will not exceed 40 hours per week. Telework may be authorized to support the research schedules.

Mandatory Qualifications

• Have a bachelors degree (preferably in a STEM-related field) or equivalent and preferably, but not required, meet technical and experience prerequisites to be qualified to test for HRPP professional certification.
• Have experience working directly within the Human Research Protections Program (HRPP) office, ideally within the Department of Defense (DoD), as an IRB analyst.
• Experience must have included not only the technical review and human research protections compliance administrative processing of research proposals but also the technical administration of an IRB.
• Have at least two (2) years (within the past five (5) years) of direct experience as an Institutional Review Board (IRB) analyst, including pre-review and preparation of research for IRB approval, as well as experience in the administration of an IRB. Specialized administration experience shall include
  • Independent technical drafting and processing of IRB agendas.
  • Committee minutes and determination letters of the IRB are all within the federal regulatory requirements of IRB administration.

• Have specialized training, working knowledge, and experience in creating or assessing scientific practices, research methodology, and statistical research designs.
• Have IRB specialized administration experience, including knowledge and application of federally mandated IRB procedures, regulatory review pathways, handling of reported adverse events, and non-compliance.
• Have knowledge of and experience in drafting and ensuring regulatory procedures
• for:
  • Federal Wide Assurances issued from Health and Human Services
  • Human research Conflicts of Interest
  • Individual Investigator Agreements
  • Institutional Review Board (IRB) Review Agreements
• Have at least one (1) year of current (within the past three (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 programs or administrative experience that would enable contractors to become capable of performing such reviews.
• Have prior experience in independently coordinating and drafting correspondence related to human research protection official (HRPO) 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 the contractor to learn and apply research protections specific requirements within one month.
• Experience in independently coordinating and drafting correspondence related to human research protection official (HRPO) 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 the contractor to learn and apply research protections specific requirements within one month.
• Have prior experience in the development, planning, hosting and delivering HRPP and IRB specific training and education materials, including but not limited to web-site materials, workshops, training presentations, quality assurance visits and discussions related to HRPP general requirements, and specifically IRB administration, IRB requirements, multi-site research compliance designs, Conflicts of Interest, FWAs, and IRB review agreements.
• Have knowledge, skill, training, experience and ability to be highly proficient in the use of desktop computer workstations 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 protocol management systems.

Duties/Responsibilities:

• Provide human subjects use research protections scientific, 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 in general, as well as specific to the bio-technology domain. IR supports the Air Force Research Laboratory (AFRL) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) program (AFWERX) and routinely reviews SBIR/STTR proprietary material.
• Conduct independently all aspects of the IRB process and regulatory requirements, including technical and scientific IRB analytical requirements, IRB processing requirements, and IRB technical regulatory administration requirements.
• Create and manage IRB planning, agenda, committee minutes, records management, adverse event reporting, and compliance reporting in accordance with a myriad of regulations pertaining to IRB.
• Work within the 711 HPW/IR office and shall analyze/evaluate contract proposals, statements of work, Conflicts of Interest, FWAs, IRB review agreements, multi-site study plans, 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.
• Shall align to ensure that prior education, training, and/or experience enable the Institutional Review Board Analyst to be skillfully knowledgeable about federal and commercial IRB administrative, scientific, and technical requirements and unique aspects of biotechnology in human-centric research.
  • Tasks shall be of a specialized variety and the Institutional Review Board Analyst shall independently apply knowledge of and discharge timely analysis of human subject 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_AFI40-402; DODI 3216.01, AFRLI 40-402, 21 CFR, 15 U.S.C 2051-2089.
• Tasks require high degrees of proficiency in English writing and oral communication. These capabilities, obtained through higher educational academics or experience, shall enable the Institutional Review Board Analyst to independently draft e-mail and official correspondence to facilitate the administrative and regulatory lifespan of human subject research programs and studies pursuant to HRPP and IRB federal requirements.
• The Institutional Review Board Analyst shall be qualified to develop, plan, host, and deliver HRPP and IRB-specific training and education materials in various venues: website materials, workshops, training presentations, and quality assurance visits and discussions related to IRB processes and requirements, as well as human research protections official administrative processing.

• Use prior knowledge, skill, training, and experience to independently use a desktop computer workstation or accomplish tasks in Microsoft Word, Microsoft PowerPoint, and Excel, as well as internet applications including e-mail, worldwide 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 train customers in using such a system. Utilize electronic and web-based systems to administer an IRB and IRB actions.
• Develop and maintain 711 HPW/IR human research protections compliance databases and web-based systems, including those pertaining to IRB, for administrative management of tracking and documenting human research protections training, research proposal reviews, human research HRPO approval coordination, and IRB actions.

COMPENSATION AND BENEFITS:

• Competitive Compensation package
• Comprehensive benefits including medical, dental and vision options.
• Outstanding career growth potential.

ABOUT US:

Fidelity Partners is a Inc. 5000, USA company that provides medical, technical, logistical, and administrative services to the federal government and commercial Clients across the country. Fidelity offers competitive salaries and benefits packages.

Qualified applicants are encouraged to learn more about us at www.fidelitypartners.org or call us at

(210) 822-4005

or Join our Team

Fidelity Partners provides equal employment without regard to race, color, religion, sex, national origin, age, disability, or in accordance with applicable federal state, and local laws (EoE).