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Magellan Health · 1 month ago

Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Falls Church VA 22041 Fed2 5205 Leesburg Pike

Full-time

Onsite

Mid Level

$58K/yr - $94K/yr

4+ years exp

Magellan Health is a leading healthcare company focused on human research protection. The Human Research Protection Specialist will assist with oversight of human research protection programs and ensure compliance with regulations and standards.

BiotechnologyHealth CareHospital

No H1B

Security Clearance Required

Responsibilities

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, research subject protection, and institutional and investigator compliance

Serves as point-of-contact for assigned Commands and provide 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 the following tasks:

Periodically reviews Command Assurances for the protection of human research subjects. Assurance reviews can include an application, Command Instructions, IRB roster, IRB Policies and Procedures, agreements with other Commands, and summaries of training for key staff

Reviews and analyzes institution-specific Management Plans, Instructions, policies, and procedures. Provide a written report for each assessment including specific findings and recommendations to further institutional compliance and/or initiate quality improvements

Conducts site inspections and assist visits with Commands on a regular basis. Coordinate with the Command staff and other site inspection or assist visit team members, including leadership, if any. Site inspections and assist visits may include: interviews with human research protection staff, interviews with researchers, review of Command research files, and review of investigator files. Evaluate and assess findings objectively and integrate all activities and results into a final Assessment report or summary

Headquarters Level Review of IRB reviewed protocols for which the Program has regulatory oversight. Provide a written report for each protocol reviewed and keep track of trends. Communicate findings to IRB staff to ensure compliance

Serve as a subject matter expert to Institutional Officials, Human Research Protections Officers (HRPOs), Institutional Review Board (IRB) members and staff, and other HRPP staff on human research protection and compliance regulations, policies, and procedures. Subject matter expertise includes knowledge of human research ethical foundations, federal regulations, requirements, GCP standards, and standards for the responsible conduct of research

Serves as site inspection or assist visit team member for other HRPP staff members, as needed

Performs full range of subject matter research and analyses

Interprets results to determine validity and significance. Prepare written reports presenting the results, interpretations, conclusions, and impact analysis

Identifies need for new processes, systems, methods or approaches, guidance documents, standards, and training needs

Qualification

Human research protectionRegulatory complianceTechnical writingAnalytic skillsProject managementChange managementMicrosoft OfficeCommunication skillsProblem solvingNegotiating skills

Required

Minimum of 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 application of the Common Rule and subparts B, C and D; HIPAA; and other human research protection regulatory requirements

Exceptional communication skills (verbal and written), with proven technical writing abilities (Writing sample required to be provided)

Superior analytic, problem solving, and negotiating skills

Excellent demonstrated project and time-management skills

Demonstrated success in change management

Travel to domestic and international destinations possible Travel required up to 8 times per year

Human subjects protection and regulatory compliance certification (or obtained within 6 months of hire)

Must be able to work independently in Microsoft Windows 7 and Microsoft Office 2010 (Excel, Outlook, Powerpoint, Publisher, and Word)

Interim Secret Clearance required to start