DHA Human Research Protection Functional Analyst

Eagle Global Scientific, LLC (EGS) is seeking a IRB Program Specialist to support the Defense Health Agency’s Research and Engineering Directorate (R&E) via Hybrid schedule (both remote and onsite in Falls Church, VA). 

The IRB Program Specialist for the Office of Research Protections (ORP) shall support the DHA ORP Director for human subjects’ protection and research integrity and misconduct programs.  The branch promotes policies and procedures that facilitate timely, effective reviews of human subject research along with research integrity and misconduct to ensure that research is conducted IAW applicable rules and ethical guidelines.  The support for the ORP office may include, but not be limited to, expertise in compliance with Federal and other regulations/directives.

Responsibilities:

• Provide program analysis and support for the Defense Health Agency (DHA) Office of Research Protection (ORP). ORP, as the DHA Component Office for Human Research Protections, provides oversight and guidance to the human research protection programs (HRPPs) at military medical and dental treatment facilities. ORP is also responsible for the DHA Research Integrity and Misconduct program and supports the DHA Animal Care and Use program.
• Provide subject matter expertise to ORP in implementation of/ensuring compliance with 32 Code of Federal Regulations (CFR) part 219, 45 CFR part 46 Subparts A-E, 21 CFR parts 50 and 56, DoD Instructions 3216.01 and 3216.02, 10 United States Code part 980, and other applicable Federal, State, and local regulations.
• Provide program analysis and support for the HRPP Assurance granting and oversight process, including conducting reviews of Assurance requests, HRPP standard operating procedures (SOPs), and Institutional Review Board (IRB) policies and procedures. Conduct audits of DoD institutions that request a new or renewed HRPP Assurance to ensure compliance with
• Support the development of research policy, to include organizing working groups, and the drafting and coordination of Defense Health Agency Procedural and Administrative Instructions (DHA-PI and DHA-AI) that implement the Human Research Protections Program across the Military Health System.
• Perform program analysis and support for the quality assurance (QA) and research integrity initiatives of the ORP.
• Support conducting formal and informal reviews of the actions taken by research review systems, including IRBs, Human Research Protection Officials, and Exemption Determination Officials (EDOs), including reviewing protocol application, modifications, and status report submissions for government approval or concurrence.
• Coordinate and facilitate meetings by providing attendees all necessary materials before the meeting, arranging conference rooms, attending meetings, and preparing a summary of the meeting proceedings.
• Provide support in the development and maintenance of training programs for researchers, reviewers, and institutional officials for research involving humans as subjects and research involving animals.
• Provide support to the government with investigating and resolving unanticipated problems and allegations of noncompliance or research misconduct.
• Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence) for and to the ORP stakeholder communities.
• Provide support for the Electronic Institution Review Board (EIRB), which is the designated electronic filing system, to include coordinating and facilitating Executive Steering Committee (ESC) and ESC subcommittee meetings, acting as the primary point of contact with the EIRB program management office, maintaining the EIRB change request backlog, providing training in the use of the EIRB system, and drafting policy, guidance, and instructional guidance in the use of the EIRB system.
• Developing and revising policy guidance, management plan, processes, trainings, and agreements for other programs under the preview of ORP including but not limited to Research Integrity and Misconduct (RIM) program.
• Other duties as assigned.

Requirements:

• Minimum Bachelors degree in an appropriate scientific discipline with 3+ years of related HRPP experience
• Experience working in a human/animal research protection environment, preferably in a compliance, oversight, regulatory, or advisory role.
• Prior experience within the DoD healthcare systems strongly preferred.
• Must be a US Citizen with ability to obtain a security clearance.
• Ability to successfully pass a DHA background investigation.

Eagle Global Scientific, LLC offers a competitive benefits package to include: paid holidays, paid time off including sick and vacation leave, medical, dental and vision insurance, flexible spending accounts, short and long term disability, company paid life insurance, 401(k) with a company match and discretionary profit sharing and tuition reimbursement.