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Human Subject Protection Specialist

2 months ago

Arlington, United States Allegient Defense Full time

Allegient Defense is a Small Business providing technically-oriented services from program management to advanced systems integration and engineering. We support Government and prime system integrators with engineering and management expertise. Allegient Defense helps clients with challenging Science & Technology, Engineering Acquisition, and Program Management Mission requirements. With a 90% Veteran Hiring rate, our staff quickly embed with clients, identify critical needs, and work relentlessly to accomplish the mission.


Allegient Defense is a leader in advanced technology research and solutions development, and we are growing quickly. We are looking to staff a Sr. Human Research Protection Protocol Compliance Specialist for one of our DoD clients.


Position Description:

Sr. HRPP Specialist to provide technical support to the Office of Naval Research (ONR). The HRPP Compliance Specialist will assist in preliminary review of allegations of non-compliance and research misconduct; assist in identification of areas of concern, corrective action(s) and development of reports and recommendations; in addition, assist in development of forms, data, and other human research regulatory compliance items in a centralized, relational database suitable for standard and ad-hoc reporting and analysis. This position requires a critical thinker who can extract meaning from complex data relationships, identify trends, opportunities, and solutions related to customer policy and program areas. Applicants must have a passion for their work, be innovative, and possess strong verbal and written communication and analytic skills. The ideal applicant will have demonstrated proficiency and understanding of compliance processes associated with Human Research Protection Protocol programs.


Job Description/Responsibilities:

  • Develop program/project management tools that help define, observe, and assess actions that implement human research regulatory compliance.
  • Assist in the review and assessment of DON Commands, institutions, and non-DOD collaborators for compliance with applicable Federal, DOD and DON requirements for the protection of human subjects in research.
  • Compile HRPP-related metrics reports for DON HRPP.
  • Conduct preliminary review of unanticipated problems involving risks to subjects or others (UPIRTSOs), allegations of serious or continuing non-compliance and research misconduct; assist in identification of areas of concern, corrective action(s) and development of reports and recommendations.
  • In conjunction with DON personnel, assist in evaluation of human research protection programs at laboratories, training commands, operational commands, systems commands, and DON-supported research involving human subjects performed by non-DOD institutions through periodic on site assist visits and site inspections.
  • Assist in conducting headquarters-level post-approval review of human research protocol submissions, including Institutional Review Board (IRB) meeting minutes to monitor compliance with Federal, DOD and DON human research protection requirements as part of a continuing quality improvement program. Write a summary of the findings for each review and after review by government personnel, archive into ONR/DON HRPP IT management system. Complete government provided training to utilize DON HRPP specific IT tools/systems during performance, including but not limited to the Research Protections Information Technology Management System (RPITMS).
  • Assist in development of forms, data, and other human research regulatory compliance items in a centralized, relational database suitable for standard and ad-hoc reporting and analysis.
  • Assist program office in the development of HRPP policies and procedures, including Work Instructions.
  • Perform clerical and administrative duties including: conference package preparation, tracking human research protection training, managing the DON HRPP human research protection training database and files, teleconference and meeting set-up, provide email coverage for the programs organizational email, and other routine office tasks.
  • Provide support and human subject protection expertise for human research protections in the Systems Commands, operational forces, training commands, and DON-supported research involving human subjects in accordance with 32 CFR Part 219, DoDI 3216.02 and SECNAVINST 3900.39E CH-1.
  • Assist with preparing and drafting presentations
  • Travel may be required.


Knowledge, Skills, and Abilities - Required:

  • Bachelor’s degree or higher from an accredited college/university.
  • At least five (5) years of work experience in human research protection.
  • Demonstrated experience in working with federal regulations, to include DOD/DON regulations and policies.
  • Demonstrated experience reviewing human subject research and assessing it for compliance with federal regulations and guidance.
  • Demonstrated experience writing HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders.
  • Demonstrated experience preparing assurance packages to ensure compliance with federal regulations.
  • Demonstrated experience inspecting and auditing HRPP stakeholders
  • A Secret Clearance or an interim Secret Clearance before onboarding at ONR.


Desired:

  • Demonstrated experience with both medical and non-medical research conducted and supported by DOD.
  • Demonstrated experience working with senior leadership in the DON HRPP.