Human Research Protection Specialist/PM

Work Location (100% Remote)

Human Effectiveness Directorate

711th Human Performance Wing

2800 Q Street, Building 824

Wright-Patterson AFB, OH 45433-7913

Citizenship Requirements: US citizenship is required.

Clearance Requirements: Tier 1 Background Investigation (Standard Form 85).

Type of Employment: Part-time 1128 hours per year. 24+/- hours per week.

Period of Performance: 23 May 2024 22 May 2027

Estimated Pay: $80,000 - $85,000 year.

Travel: Travel is required for this position.

Summary of Services

The Technical Human Research Protection Specialist/ Program Manager will support the Human Effectiveness Directorate in providing technical review and Institutional Review Board (IRB) and Human Research Protections Office (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.

Working Hours

This position is 100% telework . Work schedule is normally from 0730 1630, Monday through Friday, except federal holidays; however, there may be times when it is necessary for the contractor to work before or after duty hours in support of specific tasks. Although schedule may have to be flexible, it will not exceed 24 hours per week.

Mandatory Qualifications

• Possess at least Five (5) years experience as a human research protections regulatory specialist within a Department of Defense (preferably Air Force) human research protections program (HRPP) office.
• Possess the ability to prepare research proposals submissions to an IRB office and manage varies research portfolios.
• Process Two (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.
• Shall have Two (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.
• Shall have 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.
• Shall 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, worldwide web searches, electronic based research, web-page maintenance, and cloud based/web-based research protocol management systems.
• Shall have prior experience in tracking and establishing IRB protocol processing metrics and workload outcomes.

Highly Desired Qualifications

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

Duties/Responsibilities

• Provide technical review and IRB and HRPO specific administrative processing of others research proposals.
• Independently provide critical guidance to researchers, IRB Program Director, and executive staff regarding human subject 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 711th HPW/ Institutional Review Board (IR) customers to confirm such regulatory compliance.
• Ensure that prior education, training and/or experience enables the Contractor to be skillfully knowledgeable with federal and Department of Defense (DoD) IRB administrative requirements.
• 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 Administration requirements.
• Be proficiency in English writing and oral communication.
• 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.
• Perform tasks for 711th HPW/IR within an electronic web-based system and shall train customers on the use of such a system.
• Analyze and maintain 711th HPW/IR databases 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, U.S. School of Airspace Medicine, Human Effectiveness Directorate, and the U.S. Air Force Surgeon General Research Compliance (SGE-C) Directorate, and their related staff/contractors, and other diverse research collaborators in order to further administrative processing of human subjects research submissions.
• 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.

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 or or call us at or apply at

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).