Institutional Review Board Analyst

SierTeK proudly serves our clients by providing expertise in the Program Management, Information Technology, and Administrative Support domains. Founded in 2007 as a minority and service-disabled veteran-owned company, we serve as prime- and subcontractor for a multitude of Federal Department of Defense contracts. By focusing on continual improvement, our services remain at the forefront of our industry, and we pride ourselves on delivering our services with the highest degree of integrity.

SierTeK Ltd. is seeking an Institutional Review Board Analyst to support an opportunity at Wright Patt AFB. 

Responsibilities

• Contractor shall 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 AFRL SBIR/STTR program (AFWERX) and routinely reviews SBIR/STTR proprietary material.
• Contractor shall conduct independently all aspects of IRB process and regulatory requirements, including technical and scientific IRB analytical requirements, IRB processing requirements, and IRB technical regulatory administration requirements. Shall 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.
• 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, scientific and technical requirements, and unique aspects of biotechnology in human centric research. Tasks shall be of a specialized variety and Contractor 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_AFI 40-402; 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 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 pursuant to HRPP and IRB federal requirements.
• Qualified to develop, plan, host and deliver HRPP and IRB specific training and education materials in various venues: web-site 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, 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 utilize electronic, and web-bases systems to administer an IRB and IRB actions.
• Develop and maintain 711 HPW/IR human research protections compliance data bases and web-based systems, including those pertaining to IRB, for administrative management of tracking and documenting human research protections training, research proposal reviews, and human research HRPO approval coordination and IRB actions.

Qualifications

• Experience working directly, within a Human Research Protections Program (HRPP) office, ideally within the Department of Defense (DoD), as an IRB analyst. Such 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.
• At least two current years (within the past 5 years) of direct experience as an Institutional Review Board (IRB) analyst, to include 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 agendas, committee minutes, and determination letters of the IRB all within the federal regulatory requirements of IRB administration. IRB specialized administration experience will also include knowledge and application of federally mandated IRB procedures, regulatory review pathways, handling of reported adverse events and non-compliance.
• 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
• 1 year current (with the past 3 years) knowledge and experience in IRB specific compliance requirements of bio-technology devices, to include the general requirements of Software as a Medical Device and of Abbreviated Experimental Device Exemptions for biotechnology devices.
• Specialized training in, working knowledge of, and experience in creating or assessing scientific practices, research methodology, and statistical research designs.
• Familiar with HRPP and IRB administration including industry-recognized research protocol tracking systems and procedures for technical protocol reviews for administrative compliance, as well as electronic processes for IRBs and multi-site IRB practices.
• Bachelor’s degree (preferably in a STEM related field) or equivalent and preferably, but not required, meets technical and experience prerequisites to be qualified to test for HRPP professional certification.
• 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.
• 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 contractor to learn and apply research protections specific requirements within one month.
• 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, and 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.
• 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.