Senior IRB Research Scientist Job in Not Specified, Virginia US

Senior IRB Research Scientist

Job Duties: Assist in the development and implementation of Army Headquarters level 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. Provide consultation for updating the Human Research Protection Program at the component level. Provide expert written technical reviews of application packets for DoD Assurances for the Protection of Human Research Subjects (Assurances). Application packets include, at a minimum, a DoD Assurance Agreement, Human Research Protection Program (HRPP) Plan, IRB roster, IRB Policies and Procedures, and summaries of HRPP training for key HRPP staff. Assess institutional compliance with DoD Assurances by preparing, planning, conducting, and reporting on periodic HRPP assessments of institutions holding DoD Assurances. Determine compliance through review and analysis of institution-specific Human Research Protection Program (HRPP) Management Plans, policies and procedures; interviews with key HRPP personnel; review and analysis of IRB minutes, research files, and investigator files. Provide a written report for each assessment including specific findings and recommendations to further institutional compliance and/or initiate quality improvements. Participates as requested in site assistance visits for quality improvement purposes, or for cause investigations. Performs all services either independently or with the assigned site visit leader, evaluates and assesses findings objectively, and integrates all activities and results into a final assessment report. Conduct Headquarters Level Administrative Review (HLAR) of IRB reviewed protocols for which AHRPO has regulatory oversight. Provide a written report for each protocol reviewed. Work with IRB staff to ensure compliance. Serve as subject matter expert to institutional officials, human protection administrators, Institutional Review Board (IRB) members and other HRPP staff on human subject protection and compliance policies and procedures. Subject matter expertise to include knowledge of human research ethical foundations, federal regulations, DoD and Army requirements, GCP standards, and standards for the responsible conduct of research. Perform full range of subject matter research and analyses. Interprets results to determine validity and significance. Prepares a written report presenting the results, interpretations, conclusions, and impact analysis. Identifies need for new processes, systems, methods or approaches, guidance documents, standards, and training needs. Requirements: Minimum of 4 years experience in IRB management and/or administration Minimum of 4 years experience with electronic document management systems and report generation Subject matter expertise in human subjects protection, including application of the Common Rule and Subparts B, C and D; the Food and Drug Administration (FDA) regulations concerning investigational devices and drugs; HIPAA; and other human subjects protection regulatory requirements Exceptional communication skills (verbal and written), with proven technical writing abilities, writing sample required Superior analytic, problem solving, and negotiating skills Excellent demonstrated project and time-management skills Demonstrated success in change management Travel required Human subjects protection and regulatory compliance certification (or obtained within 6-months of hire) Highly Desirable: Experience conducting human subject research Previous DoD experience in the area of human subjects protection and regulatory compliance Desired Education Level: Masters degree (MBA, MHCA, or MPH in Public Health education with focus in U.S. Healthcare) JD preferred with experience in Health Law 4+ years post advanced-degree experience in relevant field(s) Our Equal Employment Opportunity Policy: Armed Forces Services Corporation (AFSC) is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. Physical Requirements: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. General Office Demands: * Must be able to operate general office equipment including but not limited to: computer, phones and related media and information devices on most or all workdays * Ability to communicate and interact with others, both in person and/or by telephone to conduct business * Working under time pressure * Working rapidly for long periods to meet deadlines * Must be able to travel as needed and adhere to AFSC travel policies and procedures. * Physical requirements can typically be characterized as sedentary: work involves exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Major Job activities and mental requirements: * Multiple concurrent tasks * Ability to perform under stress * Reading and comprehension * Writing * Problem solving * Confidentiality * Customer contact