Primastep LLC
Human Research Compliance Analyst (DoD/HRPP)
Primastep LLC, Arlington, Virginia, United States, 22203
Company Description
Job Description
We are seeking a
Human Research Compliance Analyst
to support a long-term contract with the Office of Naval Research in Arlington, VA. This role is vital for analyzing complex data, identifying trends, and ensuring compliance with policies and programs related to human research protections.
The ideal candidate will possess a deep understanding of federal regulations for human subject research, strong analytical and communication skills, and a proactive, solutions-oriented approach.
Key Responsibilities Develop, enhance, and manage project management tools supporting the agency-wide Human Research Protection Program (HRPP). Review and assess compliance of agency units, laboratories, and external collaborators with federal and agency-specific human research regulations. Prepare and review Federalwide Assurance (FWA) and Department of Defense (DoD) Assurance packages for internal and sponsored research programs. Conduct on-site visits, audits, and inspections to evaluate HRPP compliance, including administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB)-approved studies. Investigate unanticipated problems or incidents of noncompliance that pose risks to research subjects; prepare reports and recommend corrective actions. Support the development and maintenance of program databases, processes, metrics, forms, standard operating procedures (SOPs), checklists, and other compliance tools. Serve as a subject matter expert on relevant regulations, including 32 CFR Part 219, DoDI 3216.02, and SECNAVINST 3900.39E CH-1. Assist in preparing reports, presentations, and other deliverables to support the agency's HRPP oversight and compliance functions.
Qualifications
Required Qualifications: At least 3 years of experience in Human Research Protection or related compliance roles. Bachelor's degree from an accredited institution. U.S. citizen with current Secret clearance. Proven experience preparing or reviewing Assurance packages to ensure compliance with federal regulations. Experience conducting inspections and audits of HRPP stakeholders to verify regulatory compliance. Strong knowledge of federal, DoD, and Department of Navy (DON) regulations related to human subject research. Demonstrated ability to draft HRPP policies and guidance for IRBs, investigators, and institutional stakeholders.
Preferred Qualifications: Completion of CITI training in Human Subjects Research or IRB Administration. Previous experience supporting military or federal human research programs is highly desirable.
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
Human Research Compliance Analyst
to support a long-term contract with the Office of Naval Research in Arlington, VA. This role is vital for analyzing complex data, identifying trends, and ensuring compliance with policies and programs related to human research protections.
The ideal candidate will possess a deep understanding of federal regulations for human subject research, strong analytical and communication skills, and a proactive, solutions-oriented approach.
Key Responsibilities Develop, enhance, and manage project management tools supporting the agency-wide Human Research Protection Program (HRPP). Review and assess compliance of agency units, laboratories, and external collaborators with federal and agency-specific human research regulations. Prepare and review Federalwide Assurance (FWA) and Department of Defense (DoD) Assurance packages for internal and sponsored research programs. Conduct on-site visits, audits, and inspections to evaluate HRPP compliance, including administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB)-approved studies. Investigate unanticipated problems or incidents of noncompliance that pose risks to research subjects; prepare reports and recommend corrective actions. Support the development and maintenance of program databases, processes, metrics, forms, standard operating procedures (SOPs), checklists, and other compliance tools. Serve as a subject matter expert on relevant regulations, including 32 CFR Part 219, DoDI 3216.02, and SECNAVINST 3900.39E CH-1. Assist in preparing reports, presentations, and other deliverables to support the agency's HRPP oversight and compliance functions.
Qualifications
Required Qualifications: At least 3 years of experience in Human Research Protection or related compliance roles. Bachelor's degree from an accredited institution. U.S. citizen with current Secret clearance. Proven experience preparing or reviewing Assurance packages to ensure compliance with federal regulations. Experience conducting inspections and audits of HRPP stakeholders to verify regulatory compliance. Strong knowledge of federal, DoD, and Department of Navy (DON) regulations related to human subject research. Demonstrated ability to draft HRPP policies and guidance for IRBs, investigators, and institutional stakeholders.
Preferred Qualifications: Completion of CITI training in Human Subjects Research or IRB Administration. Previous experience supporting military or federal human research programs is highly desirable.
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)