CBAI & Associates

Compliance Specialist (HHRP)

US-VA-Arlington
Job ID
2017-1305
Category
Program Management
Type
Regular Full-Time

Overview

CBAI and Associates is seeking a Compliance Specialist to provide Human Research Protection Program (HRPP) support to the Office of Naval Research (ONR) in Arlington, VA.

Responsibilities

  • Assist with the development of 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 Code 343 and DON HRPP.
  • Assist with 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.
  • 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.
  • 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 3900.39D.
  • Assist with preparing and drafting presentations.

Qualifications

  • Bachelor’s degree and three (3) years of work experience in human research protection.
  • Experience preparing assurance packages to ensure compliance with federal regulations.
  • Experience inspecting and auditing HRPP stakeholders.
  • Experience with both medical and non-medical research conducted and supported by DOD.
  • Experience working with senior leadership in the DON HRPP.
  • Must be able to obtain and maintain a government Secret Clearance.


 

 

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