Sr. HRPP Specialist

BCS Allegient; Arlington (VA); Hybrid; USD 100,000 - 120,000; Full time

Job summary

BCS Allegient, Arlington, VA, seeks a Sr. HRPP Specialist to support the Office of Naval Research. Hybrid work up to 3 days on-site in Arlington.

The role focuses on HRPP compliance, review of allegations, development of reports, and policy guidance for federal regulations protecting human subjects. Ideal candidate has a SECRET clearance, a Bachelor's degree, and at least five years in human research protection with strong analytical and communication skills.

Qualifications

• Bachelor’s Degree from an accredited college or university.
• Five years of work experience in human research protection.
• Demonstrated experience with federal regulations including DOW/DON and related policies.
• Experience writing HRPP-related policy and guidance for IRBs, investigators, and HRPP stakeholders.
• Experience inspecting and auditing HRPP stakeholders.

Responsibilities

• Develop program/project management tools to define, observe, and assess HRPP compliance actions.
• Review DON Commands, institutions, and non-DOW collaborators for compliance with federal requirements.
• Review UPIRTSOs and allegations of non-compliance; identify areas of concern and develop reports.
• Evaluate HRPP programs at laboratories, commands, and DON-supported research involving human subjects.
• Assist with headquarters-level post-approval review of HRPP submissions and IRB minutes to monitor compliance.
• Archive findings into the HRPP IT management system after review.
• Complete government training on DON HRPP IT tools.
• Develop HRPP forms and data for reporting and analysis.
• Support HRPP policy development including Work Instructions.
• Provide HR subject protection expertise for DON systems and commands.
• Assist with preparing and drafting presentations.

Skills

Security clearance

Analytical skills

Communication skills

Education

Bachelor’s Degree

5+ years HRPP experience

Job description

BCS Allegient has a 35-year history of helping government, research, and private sector clients implement their programs and missions to achieve success. We offer a breadth of professional support services in the areas of business management, communications, systems engineering, analysis, mission execution, and organization performance. BCS Allegient has an immediate opening for a Sr. HRPP Specialist to join our team supporting the Office of Naval Research in Arlington, VA.

Job Location: Hybrid up to 3 days a week onsite in Arlington, VA.

Salary Range: $100K-$120K depending on experience.

Position Description:

The HRPP Compliance Specialist will assist in preliminary review of allegations of non-compliance and research misconduct; assist in identification of areas of concern, corrective action(s) and development of reports and recommendations; in addition, 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. This position requires a critical thinker who can extract meaning from complex data relationships, identify trends, opportunities, and solutions related to customer policy and program areas. Applicants must have a passion for their work, 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 Protocol programs.

Job Description/Responsibilities:

• Develop 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-DOW collaborators for compliance with applicable Federal, DOW and DON requirements for the protection of human subjects in research.
• Conduct 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-DOW 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, DOW and DON human research protection requirements as part of a continuing quality improvement program.
• Write a summary of the findings for each review and after review by government personnel, archive into ONR/DON HRPP IT management system.
• Complete government provided training to utilize DON HRPP specific IT tools/systems during performance, including but not limited to the Research Protections Information Technology Management System (RPITMS).
• 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 3900.39E CH-1.
• Assist with preparing and drafting presentations

Job Requirements

• Current SECRET Clearance or the ability to obtain a SECRET clearance
• A Bachelor’s Degree from an accredited college or university and five (5) years of work experience in human research protection
• Demonstrated experience in working with federal regulations, to include DOW/DON regulations and policies
• Demonstrated experience reviewing human subject research and assessing it for compliance with federal regulations and guidance
• Demonstrated experience writing HRPP-related policy and guidance for IRBs, investigators, and other HRPP stakeholders
• Demonstrated experience preparing assurance packages to ensure compliance with federal regulations; and
• Demonstrated experience inspecting and auditing HRPP stakeholders.

Desired additional qualifications:

• Demonstrated experience with both medical and non-medical research conducted and supported by DoW.
• Demonstrated experience working with senior leadership in DoW and DON human research protection programs.