Human Research Protection Program (HRPP) Compliance Specialist
Company DescriptionJob Description This position will provide support to the Office of Naval Research (ONR) Warfighter Performance Department.
The HRPP Compliance Specialist will assist in post approval administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB) approved research studies; assist in preliminary review of reportable events, including serious adverse events (SAEs), unanticipated problems involving risks to subjects or others (UPIRTSOs) and serious and/or continuing non-compliance; This position will assist in the review of DoN Assurance applications; assist in the conduct of on-site HRPP audits at assigned Naval commands; assist in the identification of areas of concern, development of corrective action(s) and recommendations, and drafting of reports; in addition, assist in development of forms, checklists, standard operating procedures, and other human research regulatory compliance tools.
DUTIES AND
Responsibilities:
Developing, refining, and managing project management tools for an agency-wide human research protections program; Reviewing and assessing agency commands, laboratories, and extramural collaborators for compliance with Federal-level and agency-specific requirements for the protection of human research subjects; Preparing and reviewing Federalwide and DoD Assurance packages for agency components and sponsored entities with human subjects research programs; Carrying out evaluations of unanticipated problems involving risks to subjects or others in agency-sponsored research projects, to include issues involving noncompliance, and developing reports and recommendations for corrective actions.
Conducting post-approval administrative reviews of human research protocol submissions, to include evaluating Institutional Review Board (IRB) proceedings and meeting minutes, to monitor compliance and support continual quality improvement efforts; Developing and updating processes, materials, and databases for the agency's human research protections program and its compliance and oversight functions, and assisting with the generation of reports, metrics, presentations, and other program deliverables; and Providing subject matter expertise and consultation on complex program-level and project-specific initiatives for ensuring the protection of human subjects in all agency-sponsored research activities.
Qualifications This position requires a critical thinker who can extract meaning from complex data relationships, identify trends, opportunities, and solutions related to client policy and program areas.
Applicants must have a passion for human research protections, 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 Programs (HRPP).
Bachelor's degree or higher from an accredited college/university.
At least three (3) years of work experience in human research protection.
Demonstrated experience preparing or reviewing assurance packages to ensure compliance with federal regulations.
Demonstrated experience inspecting and auditing HRPP stakeholders.
Knowledge of federal regulations, including DoD and DoN specific requirements, applicable to the conduct of medical, social, and behavioral research.
Ability to work with senior leadership in the DoN HRPP.
Additional Information Job Location:
Arlington, VA Remote Work:
Up to 80% Job Type:
Full-Time Clearance:
Eligible for SECRET clearance Pay:
Up to $95K/yr (Depends on Experience) Recommended Skills Administration Analytical Auditing Communication Consulting Databases Estimated Salary: $20 to $28 per hour based on qualifications.
The HRPP Compliance Specialist will assist in post approval administrative reviews of Department of the Navy (DON) Institutional Review Board (IRB) approved research studies; assist in preliminary review of reportable events, including serious adverse events (SAEs), unanticipated problems involving risks to subjects or others (UPIRTSOs) and serious and/or continuing non-compliance; This position will assist in the review of DoN Assurance applications; assist in the conduct of on-site HRPP audits at assigned Naval commands; assist in the identification of areas of concern, development of corrective action(s) and recommendations, and drafting of reports; in addition, assist in development of forms, checklists, standard operating procedures, and other human research regulatory compliance tools.
DUTIES AND
Responsibilities:
Developing, refining, and managing project management tools for an agency-wide human research protections program; Reviewing and assessing agency commands, laboratories, and extramural collaborators for compliance with Federal-level and agency-specific requirements for the protection of human research subjects; Preparing and reviewing Federalwide and DoD Assurance packages for agency components and sponsored entities with human subjects research programs; Carrying out evaluations of unanticipated problems involving risks to subjects or others in agency-sponsored research projects, to include issues involving noncompliance, and developing reports and recommendations for corrective actions.
Conducting post-approval administrative reviews of human research protocol submissions, to include evaluating Institutional Review Board (IRB) proceedings and meeting minutes, to monitor compliance and support continual quality improvement efforts; Developing and updating processes, materials, and databases for the agency's human research protections program and its compliance and oversight functions, and assisting with the generation of reports, metrics, presentations, and other program deliverables; and Providing subject matter expertise and consultation on complex program-level and project-specific initiatives for ensuring the protection of human subjects in all agency-sponsored research activities.
Qualifications This position requires a critical thinker who can extract meaning from complex data relationships, identify trends, opportunities, and solutions related to client policy and program areas.
Applicants must have a passion for human research protections, 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 Programs (HRPP).
Bachelor's degree or higher from an accredited college/university.
At least three (3) years of work experience in human research protection.
Demonstrated experience preparing or reviewing assurance packages to ensure compliance with federal regulations.
Demonstrated experience inspecting and auditing HRPP stakeholders.
Knowledge of federal regulations, including DoD and DoN specific requirements, applicable to the conduct of medical, social, and behavioral research.
Ability to work with senior leadership in the DoN HRPP.
Additional Information Job Location:
Arlington, VA Remote Work:
Up to 80% Job Type:
Full-Time Clearance:
Eligible for SECRET clearance Pay:
Up to $95K/yr (Depends on Experience) Recommended Skills Administration Analytical Auditing Communication Consulting Databases Estimated Salary: $20 to $28 per hour based on qualifications.
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