- Provide technical review and IRB specific administrative processing of others' research proposals and be of the kind and sufficient experience that would enable the contractor to independently provide critical guidance to researchers, IRB Program Director, and executive staff regarding human subjects' research administration, processing, standards and regulations.
- Independently analyze/evaluate research protocols and coordinate/assist investigators' efforts to guarantee efficient and timely processing of protocols and regulatory compliance and to conduct quality assurance audits of 711 HPW/IR customers to confirm such regulatory compliance.
- Knowledgeable with federal and Department of Defense IRB administrative requirements.
- Independently apply knowledge of and discharge timely analysis of human subject's 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 device research.
- Tasks require high degrees of proficiency in English writing and oral communication.
- Develop IRB protocol templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
- 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 IRB administrative processing and HRPP.
- 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.
- Perform tasks for 711 HPW/IR within an electronic web-based system and shall train customers on the use of such a system.
- Analyze and maintain 711 HPW/IR data bases and web-based systems for administrative management of research protocols, protocol related documentation/information management, and research protocol metrics for protocol processing and time management.
- Interface with the following staff offices: 711th Human Performance Wing (HPW) (USAFSAM and RH), USAF Surgeon General Research Compliance (SGE-C), and their related staff/contractors, and other diverse research collaborators in order to further administrative processing of human.
- Within the last 2 years have experience in any capacity within an HRPP office.
- Work in preparing one's own research proposals and one's own submissions to an IRB office and managing one's own research portfolio will not meet the qualifications required by this section.
- 1 year of current (within the past 3 years) personal and direct experience in IRB protocol administration.
- A Bachelor's Degree or equivalency and meet all technical and experience prerequisites to be qualified to test for HRPP professional certification, such as Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP) or other like-kind industry standard certification. Current holder of HRPP professional certification is preferred.
- At least 1 years of current (within the past 3 years) prior experience in developing IRB protocol templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
- Prior experience in independently drafting IRB or HRPO approval notices, audit result notices, non-compliance inquiries, and other such IRB related technical correspondence for IRB Chairpersons, IRB Program Directors, or HRPO Officials.
- 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 IRB administrative processing and HRPP.
- 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. Such experience shall include at least 1 year (within the past 3 years) of consecutive, daily routine use of a commercial IRB protocol administration system as an IRB administrator.
- Prior experience in tracking and establishing IRB protocol processing metrics and workload outcomes.
- Experience working directly for a Department of Defense HRPP is highly desired.
- Experience ideally shall include the technical review and IRB specific administrative processing of others' research proposals is highly desired.
- Must be able to provide OPSEC protection for all sensitive/ critical information and indicators involved.
- Must be able to obtain a NACI (Tier 1) clearance.
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Technical Program Manager - Dayton, United States - SierTeK Ltd.
Description
Job Description
Job DescriptionSierTeK 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 a Technical Program Manager to support an opportunity at Wright Patterson AFB, OH.
Please apply by using the following link:
Description
Qualifications
SierTeK is an equal opportunity employer and values diversity. Employment is decided based on qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training.
If you need assistance or accommodation due to a disability, you may contact us at
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