Sign in

Program Manager-II (IRB)

Company:
BTL Technologies, Inc.
Location:
Dayton, OH
Posted:
November 04, 2019

Posted By Premium Recruiter

Description:

OUR ORGANIZATION:

BTL Technologies, Inc. is a Texas corporation that provides contract staff augmentation to various government agencies in the United States. The company is headquartered in San Antonio, Texas, with operations at government facilities in various states. Our mission is to provide Workforce Solutions that help our clients achieve success!

OUR CUSTOMER:

The 711 Human Performance Wing (HPW) is the leader of Line of the Air Force and Defense Health Program human research efforts. The 711 HPW/Institutional Review (IR) is responsible for administering the Human Research Protection Program (HRPP). It provides regulatory compliance oversight, Institutional Review Board (IRB) review, specialized consultation, and training and education to human use researchers for a wide-range of human performance non-clinical and clinical research in support of the Air Force Research Laboratory (AFRL) mission and Air Force (AF)-wide customers, both intramural and extramural

POSITION DESCRIPTION/RESPONSIBILITIES:

** This Position is Contingent Upon Contract Award**

Provide 711 HPW/IR management and administrative support and assistance necessary to aid HRPP oversight and compliance and IRB review, primarily for Science and Technology human research and other human research as needed. Duties and responsibilities include but are not limited 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

• Apply human subjects research related regulatory requirements including 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 Administration (FDA) regulations and policy related to drug and device research

• Independently draft 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

• Develop IRB protocol templates and IRB board meeting minutes and agenda for establishment of or continued function of a HRPP office

• Develop, plan, host and deliver 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

• Use a commercial IRB protocol administration system as an IRB administrator to perform tasks for 711 HPW/IR within an electronic web-based system and train customers on the use of such a system

• Track and establish IRB protocol processing metrics and workload outcomes

• 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, RH, and HP), USAF Surgeon General Research Compliance (SGE-C), and other contractors and research collaborators in order to further administrative processing of human use research protocols and program

MINIMUM REQUIREMENTS / QUALIFICATIONS:

• Bachelor’s Degree or equivalency

• 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

• 1 year of current (within the past 3 years) experience working directly for and in a certified HRPP office as an IRB technical administrator. Such experience must have included the technical review and IRB specific administrative processing of others’ research proposals

• 1 year of current (within the past 3 years) of personal and direct experience in IRB protocol administration including industry recognized protocol tracking systems, technical protocol reviews for administrative compliance, and have personally conducted HRPP quality assurance audits of customer’s research projects

• 1 year of current (within the past 3 years) experience in developing IRB protocol templates and IRB board meeting minutes and agenda for establishment of or continued function of a HRPP office

• Experience in the development, planning, hosting and delivering HRPP training and education materials

• Education, training and/or experience to be skillfully knowledgeable with federal and Department of Defense IRB administrative requirements and have sufficient specialized knowledge of and ability to apply human subjects research

• Proficient English writing and oral communication capabilities, obtained through higher educational academics or experience that will enable independent drafting of e-mail and official correspondence as needed to facilitate the administrative and regulatory life-span of human subject research programs and studies

• 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 will 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

• Experience in tracking and establishing IRB protocol processing metrics and workload outcomes

• Must be able to travel as required

• Must be US Citizen

WE OFFER:

• Medical/Dental/Vision Coverage

• 10 Paid Holidays

• Insurance Plans

• Paid Time Off

• 401k

• Long & Short-Term Disability

• Employee Assistance Program

Contact: Debra Kent – (216) 870-3177

BTL Technologies is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.