This position provides support to the Human Health and Performance (HH&P) Directorate at NASA/JSC, specifically in support of the NASA Institutional Review Boards (IRB). The position provides technical and administrative coordination to help facilitate the review of research protocols involving human subjects. The IRB Coordinator facilitates the research review and approval process of biomedical, social, and behavioral research. An extensive understanding of human subject research regulations and federal guidance documents is critical. Work is completed in accordance with the processes and procedures that ensure compliance with federal and state laws, regulations, institutional policies, and guidelines governing human research protections.
Essential Duties and Responsibilities:
Responsible for completing all assigned training.
Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to goals and to foster a positive work environment
• Coordinate a team approach to produce the monthly NASA IRB agenda, working with other members of the team
• Review new research submissions for consistency, completeness, and compliance with federal and state regulations and institutional guidelines in preparation for convened IRB review
• Review all complete project submissions, determine review type, recommend assignment of reviewers or ancillary review, and recommend exempt status
• Communicate to Principle Investigators items that require clarification, or documents required for submission, to complete a research application for IRB review
• Participate in developing, recommending and implementing policies and procedures to assure adequate subject protections, compliance with applicable regulations and guidelines, and to enhance IRB committee operations
• Understand and remain current on relevant law, guidelines, and policies pertaining to human subjects research
• Interpret and apply federal and state laws, regulations, institutional policies, and guidelines to protect human subjects and ensure institutional compliance
• Participate in ongoing continuing education to keep current with new developments, changes in regulatory guidance and industry standards
• Analyze and interpret existing, new, and proposed regulations for program impacts
• Conduct literature searches and reviews as required for the development of IRB policies and procedures
• Record, disseminate, and maintain local IRB policies on irb.nasa.gov
• Consult with researchers prior to, during and after protocol submission to establish conformance with ethical and procedural standards
• Contribute to timely, accurate and efficient processing of study documentation and appropriate management of data systems (share folders and electronic IRB submission system)
• Review emergency requests, protocol modifications, continuations and adverse event reports for completeness and compliance with research committee standards and federal requirements
• Provide training for electronic IRB submission system and IRB general procedures to both Principal investigators and IRB members.
• Other duties as assigned