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Valiant Harbor International is a CVE Service-Disabled Veteran Owned Small Business that specializes in technical, programmatic, acquisition, compliance, and financial services for Government science and technology, research and development, and technological programs. At Valiant Harbor International, we emphasize our intense focus on helping federal government agencies identify and address organizational challenges to tailor and integrate specific solutions to solve their most difficult problems. Success is defined by our ability to meet our customers needs quickly, efficiently, and effectively we are a management consulting firm with a successful record of offering a wide range of professional, scientific, and technical services requiring a high degree of expertise and training.

Job Description Valiant Harbor International is seeking an experiencedHRPP Compliance Specialistto support our efforts for a high-profile program within the Department of the Navy's Human Research Protection Program (DoN HRPP). The DoN HRPP is responsible for oversight of approximately 1,000 research protocols for studies being conducted in world-wide locations within DoN assured commands and the civilian sector. DoN HRPP is responsible for ensuring that research involving human subjects complies with applicable federal regulations, Department of Defense (DoD) directives, DoN instructions, and policies.

The Compliance Specialist will be responsible for ensuring that all human subjects research studies are conducted in accordance with ethical standards, regulatory requirements, and institutional policies. This role involves reviewing and monitoring research protocols, providing guidance to researchers, and supporting the implementation of the institutions Human Research Protection Program (HRPP). The Compliance Specialist plays a critical role in safeguarding the rights and welfare of research participants while ensuring compliance with federal, DoD, and DoN directives.

Job Responsibilities

• Provide human subjects research protection expertise in human research related programs.
• Conduct inspections, audits, and assessments of DoN commands, institutions, and external collaborators human subject research for compliance with applicable regulations, instructions, and policies for the protection of human subjects in research.
• Collaborate with stakeholders to address any compliance issues and provide recommendations for improvements.
• Write HRPP-related policies and guidance for Institutional Review Boards (IRBs), investigators, and other stakeholders.
• Prepare assurance packages to maintain compliance with federal research regulations.
• Prepare summaries and/or reports for DON HRPP leadership for final review/approval.
• Support quality assurance and quality improvement activities.
• Develop and maintain DON HRPP guidance documentation of policies and procedures.
• Advise and assist in the development and delivery of training modules/materials.
• Travel to DoN commands, institutions, and external collaborators sites is required.

* This position is contingent upon contract award *

Requirements and Experiences

• Must be eligible for or have a current DoD Secret Security Clearance.
• A Bachelors degree from an accredited college or university and three (3) years of relevant work experience in human subject research protection. In lieu of a Bachelors degree, a High School Diploma and five (5) years of relevant work experience in human research protection may be accepted.
• In-depth understanding of federal regulations regarding human subject research protection, including DoD/DON policies and guidelines.
• Demonstrated past experience in the following areas:
  • Reviewing/assessing human subject research for compliance with federal regulations and guidance.
  • Inspecting and auditing HRPP stakeholders.
  • Reviewing compliance documents and preparing as urance packages for human subject research programs in compliance with federal regulations.
  • Assisting in the development of HRPP-related policy and guidance.
  • Collaborating with senior leadership human research protection programs; DoN HRPP and/or BUMED experience is desired.
  • Both medical and non-medical research conducted and supported by DoD is desired.

Salary Range:$100,000.00 - $115,000.00