Primastep LLC
Regulatory Compliance Specialist - Human Research
Primastep LLC, Arlington, Virginia, United States, 22201
Company Description
Job Description
We are seeking a qualified HRPP Regulatory Compliance Specialist to support the
Office of Naval Research (ONR)
in Arlington, VA. This role ensures the protection of human subjects involved in research activities by maintaining compliance with federal and Department of Defense (DoD) regulations. The ideal candidate will have a strong background in HRPP oversight, regulatory compliance, and program evaluation, along with excellent analytical and communication skills.
Note: U.S. citizenship and an active Secret clearance are required.
Primary Responsibilities: Program Management Support
Develop, maintain, and refine tools and resources to support the agency-wide HRPP. Assist in the implementation of policies and processes to strengthen compliance infrastructure.
Compliance Monitoring & Audits
Conduct evaluations of ONR commands, laboratories, and external collaborators to assess compliance with federal and DoD-specific human subjects protection requirements. Perform on-site visits, audits, and inspections-including post-approval reviews of DON IRB-approved studies.
Regulatory Documentation & Assurance Packages
Prepare, review, and submit Federalwide Assurance (FWA) and DoD Assurance packages for internal and sponsored institutions engaged in human subjects research.
Incident Review & Corrective Action
Investigate unanticipated problems and noncompliance issues affecting human subject safety. Draft incident reports and recommend corrective and preventive actions.
Policy Development & Technical Support
Draft, review, and revise HRPP-related policies, SOPs, guidance documents, and checklists for investigators, IRBs, and other stakeholders. Provide expert guidance on the interpretation and application of federal and DoD human research regulations, including:
32 CFR Part 219 (Common Rule) DoDI 3216.02 SECNAVINST 3900.39E CH-1
Reporting & Metrics
Develop and maintain databases, generate reports, and contribute to presentations and deliverables related to HRPP compliance and oversight.
Qualifications
Minimum Qualifications:
U.S. citizenship (required) Active Secret clearance (required) Bachelor's degree from an accredited college or university At least
3 years of experience
in Human Research Protection or IRB administration Demonstrated experience:
Preparing or reviewing assurance packages for compliance with federal regulations Auditing or inspecting HRPP stakeholders (IRBs, investigators, institutions) Developing or applying policies aligned with human research regulatory frameworks
Working knowledge of relevant federal, DoD, and DON regulations governing human subjects research. Preferred Qualifications:
Completion of
CITI Program
training in Human Subjects Research, IRB administration, or related modules Experience supporting HRPP compliance in a federal or DoD agency environment
Additional Information
Employment Type:
Full-Time Location:
875 N Randolph St, Arlington, VA 22203 Work Schedule:
Hybrid (up to 60% remote) Clearance Requirement:
U.S. Citizen with
Active Secret Clearance Compensation:
Up to $95,000 per year (commensurate with experience)
Job Description
We are seeking a qualified HRPP Regulatory Compliance Specialist to support the
Office of Naval Research (ONR)
in Arlington, VA. This role ensures the protection of human subjects involved in research activities by maintaining compliance with federal and Department of Defense (DoD) regulations. The ideal candidate will have a strong background in HRPP oversight, regulatory compliance, and program evaluation, along with excellent analytical and communication skills.
Note: U.S. citizenship and an active Secret clearance are required.
Primary Responsibilities: Program Management Support
Develop, maintain, and refine tools and resources to support the agency-wide HRPP. Assist in the implementation of policies and processes to strengthen compliance infrastructure.
Compliance Monitoring & Audits
Conduct evaluations of ONR commands, laboratories, and external collaborators to assess compliance with federal and DoD-specific human subjects protection requirements. Perform on-site visits, audits, and inspections-including post-approval reviews of DON IRB-approved studies.
Regulatory Documentation & Assurance Packages
Prepare, review, and submit Federalwide Assurance (FWA) and DoD Assurance packages for internal and sponsored institutions engaged in human subjects research.
Incident Review & Corrective Action
Investigate unanticipated problems and noncompliance issues affecting human subject safety. Draft incident reports and recommend corrective and preventive actions.
Policy Development & Technical Support
Draft, review, and revise HRPP-related policies, SOPs, guidance documents, and checklists for investigators, IRBs, and other stakeholders. Provide expert guidance on the interpretation and application of federal and DoD human research regulations, including:
32 CFR Part 219 (Common Rule) DoDI 3216.02 SECNAVINST 3900.39E CH-1
Reporting & Metrics
Develop and maintain databases, generate reports, and contribute to presentations and deliverables related to HRPP compliance and oversight.
Qualifications
Minimum Qualifications:
U.S. citizenship (required) Active Secret clearance (required) Bachelor's degree from an accredited college or university At least
3 years of experience
in Human Research Protection or IRB administration Demonstrated experience:
Preparing or reviewing assurance packages for compliance with federal regulations Auditing or inspecting HRPP stakeholders (IRBs, investigators, institutions) Developing or applying policies aligned with human research regulatory frameworks
Working knowledge of relevant federal, DoD, and DON regulations governing human subjects research. Preferred Qualifications:
Completion of
CITI Program
training in Human Subjects Research, IRB administration, or related modules Experience supporting HRPP compliance in a federal or DoD agency environment
Additional Information
Employment Type:
Full-Time Location:
875 N Randolph St, Arlington, VA 22203 Work Schedule:
Hybrid (up to 60% remote) Clearance Requirement:
U.S. Citizen with
Active Secret Clearance Compensation:
Up to $95,000 per year (commensurate with experience)