Technical Human Reseach Protection Specialist Program Manager

This position is for a subject matter expert specialist in Department of Defense human research protections regulatory affairs. Essential Job Functions

• Provide technical review and IRB and HRPO 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, timely processing of protocols and regulatory compliance and to conduct quality assurance audits of 711 HPW/IR customers to confirm such regulatory compliance.
• Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be skillfully knowledgeable with federal and Department of Defense 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 3216.02_AFI 40-402; DODI 6000.08, AFRLI 40-402, as well as Food and Drug.
• Tasks require 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.
• 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. The Contractor shall 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 subjects’ research submissions. The employee shall recommend solutions to improve processes and maximize mission accomplishment through efficient utilization of resources, assist with resource estimates for solutions for DoD modernization needs, and provide resource analysis support for execution of research and development projects.

Do you have experience in User training (technical support)?, Do you have a Associate’s degree?, * At least 5 years’ experience as a human research protections regulatory specialist within a Department of Defense (preferably Air Force) human research protections program (HRPP) office. Work in preparing one’s own research proposals and one’s own submissions to an institutional review board (IRB) office and managing one’s own research portfolio will not meet the qualifications required by this section.

• 2 years current (within the past 3 years) personal and direct experience in IRB protocol administration including industry recognized protocol tracking systems, technical protocol reviews for administrative and regulatory compliance, and shall have personally conducted HRPP quality assurance audits of customer’s research projects.
• Bachelor’s Degree or Associate’s Degree/two years of college plus 2 years of related work experience or 4 years of direct work experience in the field that would provide the experience, knowledge and skills that are needed to perform proficiently. Shall have or 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.
• 2 years current (within the past 3 years) or prior experience in developing IRB protocol submission templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
• 2 years current (within the past 3 years) 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.
• 2 years current (within the past 3 years) 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 IRB administrative processing and HRPP.
• Have knowledge, skill, training, experience and ability to be 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.
• Prior experience in tracking and establishing IRB protocol processing metrics and workload outcomes.
• Have a signed Non-Disclosure Agreement (NDA in place with their company based on the potential access to confidential, proprietary, and/or sensitive information. NDA shall be provided to the Government Program Manager by start of performance.

Highly Desired Qualifications

• Experience as HRPP technical expert in non-clinical, warfighter centric, human research regulatory compliance.
• Experience shall include the technical review and IRB specific administrative processing of others’ research proposals, as well as direct technical management of IRB preparation, maintenance.

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.