Magellan Federal · 1 month ago
Human Research Protection Specialist, DONHRPP, Falls Church, Virginia
Falls Church, VA
Full-time
Onsite
Mid Level
$58K/yr - $94K/yr
4+ years expMagellan Federal is seeking a Human Research Protection Specialist to assist with oversight of human research protection programs and ensure compliance with regulations. The role involves developing standards, conducting assessments, and serving as a subject matter expert on human research protection and compliance regulations.
Management Consulting
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
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
Preferred
Master's
Benefits
Short-term incentives
Comprehensive benefits package
Broad range of health, life, voluntary and other benefits and perks that enhance your physical, mental, emotional and financial wellbeing
Company
Magellan Federal
Magellan Federal—a Magellan Health company—has received recognition as a 2024 Military Friendly®, a Washington Post Top Workplaces, and MilitaryTimes Best for Vets company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Anna Sever
President and CEO
Todd Baker
Vice President of Financial Operations and Chief Financial Officer
Company data provided by crunchbase