Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Human Research Protection Specialist, DONHRPP, Falls Church, Virginia

Join to apply for the Human Research Protection Specialist, DONHRPP, Falls Church, Virginia role at Magellan Health

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, research subject protection, and institutional and investigator compliance.
• 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 the following tasks: periodically reviews Command Assurances for the protection of human research subjects; reviews and analyzes institution‑specific Management Plans, Instructions, policies, and procedures; conducts site inspections and assist visits; performs a full range of subject‑matter research and analyses; and identifies the need for new processes, systems, methods or approaches, guidance documents, standards, and training needs.
• Reviews and analyzes institution‑specific Management Plans, Instructions, policies, and procedures. Provides 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; coordinates with the Command staff and other site inspection or assist visit team members, including leadership, if any; interviews with human research protection staff, researchers, reviews of Command research files and investigator files; evaluates and assesses findings objectively and integrates 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; provides a written report for each protocol reviewed and tracks trends; communicates findings to IRB staff to ensure compliance.
• Serves as a subject‑matter expert to Institutional Officials, Human Research Protection Officers (HRPOs), Institutional Review Board (IRB) members and staff, and other HRPP staff on human research protection and compliance regulations, policies, and procedures.
• Performs full range of subject‑matter research and analyses; interprets results to determine validity and significance; prepares written reports presenting the results, interpretations, conclusions, and impact analysis.

The job duties listed above are representative and not intended to be all‑inclusive of what may be expected of an employee assigned to this job. A leader may assign additional or other duties which would align with the intent of this job, without revision to the job description.

• 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, Power point, Publisher, and Word).
• Interim Secret Clearance required to start.

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.