Human Research Protection Specialist, DONHRPP, Falls Church, Virginia
Core
Oversees human research protection programs, Institutional Review Boards (IRBs), and regulatory compliance for clinical and cross-discipline research.
Role type
Human Research Protection Specialist (Compliance & Oversight)
Builds
Compliance frameworks, assessment reports, and regulatory adherence for research programs.
Domain
Healthcare research compliance and human subject protection
Deliverable
dashboards & analysis
Required skills
Human research protection regulations (Common Rule, HIPAA), GCP standards, policy development, site inspection, regulatory compliance assessment, technical writing, data analysis
Preferred skills
Change management, project management, time management, negotiation
Technologies
Microsoft Windows 7, Microsoft Office 2010 (Excel, Outlook, PowerPoint, Publisher, Word)
Responsibilities
Develop and implement human subject protection standards and policies; conduct site inspections and assist visits; review IRB protocols and Command Assurances; provide consultation on regulatory updates; prepare written assessment and protocol review reports; serve as subject matter expert for HRPP staff.
Seniority
Mid-level, hands-on IC
