Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Magellan Health Services
United States
Workplace: OnsiteFull timeUSD 58,440 - 93,500Function: Research & Scientific (R&D)Experience: 4+ yearsEducation: bachelorsSkills: ["Communication","Technical writing","Analytic problem-solving","Negotiation","Project management"]

Assist oversight of human research protection programs, including Institutional Review Boards (IRBs) and human subject protection standards. Serve as a point of contact for assigned Commands, providing guidance, conducting compliance assessments, and preparing written reports with findings and recommendations. Perform site inspections and Headquarters-level protocol reviews with regulatory oversight. Serve as a subject matter expert on ethical foundations, federal regulations, HIPAA, GCP, and responsible conduct of research, identifying process and training needs.

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Magellan Health Services
Magellan Health Services
3 months ago

Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

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Source: Company careers pageValidated by: Fursa AI
Last checked: 15 days agoStatus: Live
Reposted: similar role first listed 7 months ago

Job Summary

Assist oversight of human research protection programs, including Institutional Review Boards (IRBs) and human subject protection standards. Serve as a point of contact for assigned Commands, providing guidance, conducting compliance assessments, and preparing written reports with findings and recommendations. Perform site inspections and Headquarters-level protocol reviews with regulatory oversight. Serve as a subject matter expert on ethical foundations, federal regulations, HIPAA, GCP, and responsible conduct of research, identifying process and training needs.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Support oversight of human research protection programs, including IRBs, standards, policies, procedures, and regulatory compliance for clinical and cross-discipline research.
  • •Assess Command compliance by reviewing Command Assurances, institution-specific management plans and policies, and producing written assessment reports with findings and recommendations.
  • •Conduct site inspections and assist visits, including interviews and file reviews, and integrate results into final assessment reports or summaries.
  • •Review IRB protocols under Program regulatory oversight, track trends, and communicate findings to IRB staff to ensure compliance.
  • •Serve as a subject matter expert on human research protection regulations, policies, and procedures, interpreting results and identifying needs for new processes, systems, guidance, standards, and training.
Travel: Low travel

Pay and Benefits

Salary: USD 58,440 - 93,500
Perks:Health InsuranceLife Insurance

Key Requirements

  • •Minimum of 4 years’ experience in human research protection and compliance oversight.
  • •Bachelor's degree in biomedical or socio-behavioral field.
  • •Subject matter expertise in human research protection, including the Common Rule (subparts B, C, and D) and HIPAA.
  • •Human subjects protection and regulatory compliance certification (or obtain within 6 months of hire).
  • •Interim Secret Clearance required to start and ability to work independently in Microsoft Windows 7 and Microsoft Office 2010.
Experience:4+ yearsHuman research protectionClinical research
Education:Bachelor's
Skills:CommunicationTechnical writingAnalytic problem-solvingNegotiationProject management
Certifications:Human subjects protection and regulatory compliance certification
Tech Stack:Microsoft Windows 7Microsoft Office 2010ExcelOutlookPowerpointPublisherWord

Eligibility

Security Clearance:Secret

Company Brief

Magellan Health Services
Provides managed behavioral health, specialty healthcare, pharmacy management, and population health services to health plans, employers, and government agencies, focusing on improving outcomes and reducing costs through integrated care solutions.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Growth: Established Company
Funding: IPO / Publicly Listed
Headquarters: Scottsdale, United States
Founded: 1969
WebsiteLinkedIn