Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Magellan Federal

The Human Research Protection Specialist will assist with oversight of human research protection programs, Institutional Review Boards (IRBs), human subject protection standards, policy and procedure development, and regulatory compliance.

• Assists in the development and implementation of human subject protection standards, policies, procedures and systems relative to clinical research and cross-discipline human subject research.
• Serves as point-of-contact for assigned Commands and provides guidance and oversight as needed.
• Provides consultation for updating regulations and policies at the component level.
• Assesses Command compliance with federal and institutional regulations and policies through periodic reviews of Command assurances, IRB policies, agreements, and training summaries.
• Reviews and analyzes institution-specific Management Plans, instructions, policies, and procedures and provides a written report with findings and recommendations.
• Conducts site inspections and assist visits with Commands, coordinating with staff and team members, interviewing staff, reviewing files, and integrating findings into an assessment report.
• Review of IRB reviewed protocols for regulatory oversight and provides written reports and trend tracking.
• Serves as a subject matter expert to institutional officials, HRPOs, IRB members and staff on human research protection and compliance regulations, policies, and procedures.
• Performs full range of subject matter research and analyses, interprets results, and prepares written reports presenting results and impact analysis.
• Identifies need for new processes, systems, methods or approaches, guidance documents, standards, and training needs.

Additional duties may be assigned that align with the intent of this job.

• Minimum 4 years’ experience in human research protection and compliance oversight.
• Bachelor's degree in biomedical or socio-behavioral field required.
• Subject matter expertise in human research protection, including Common Rule (subparts B, C,
  
  D), HIPAA, and other regulatory requirements.
• Exceptional communication skills (verbal, written) with proven technical writing abilities (writing sample required).
• Superior analytic, problem solving, and negotiating skills.
• Excellent project and time-management skills.
• Demonstrated success in change management.
• Travel to domestic and international destinations possible; up to 8 times per year.
• Human subjects protection and regulatory compliance certification (or obtained within 6 months of hire).
• Ability to work independently in Microsoft Windows 7 and Microsoft Office 2010.
• Interim Secret Clearance required to start.

• Title:
  
  Human Research Protection Specialist, DONHRPP, Falls Church, Virginia
• Grade: 24
• Work Experience
  - Required:
  
  Research
• Education
  - Required:
  
  Bachelor's
• Salary Minimum: $58,440
• Salary Maximum: $93,500

Magellan Health, Inc. is proud to be an Equal Opportunity Employer and a Tobacco‑free workplace. EOE/M/F/Vet/Disabled.

Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their position; and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.