Overview: This position provides support to the Human Health and Performance (HH&P) Directorate at NASA/JSC, specifically in support of the NASA Institutional Review Board (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 and an extensive understanding of human subject research regulations and federal guidance 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. This position is available as remote-only work. Responsibilities - Responsible for compliance with Safety, Health and Environmental Plan; must be committed to a high standard of safety and be willing and able to comply with all safety laws and all of the Company's safety policies and rules and must be willing to report safety violations to appropriate supervisory or management personnel.
- Responsible for compliance with the Quality Assurance Plan, policies, and procedures and must maintain regular and acceptable attendance level as determined by the Company.
- 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 as needed.
- As needed, provide administrative support for the NASA IRB to include agenda preparation, submission review, minutes preparation, record keeping, and related activities as required
- Review new research applications for consistency, completeness, and compliance with federal and state regulations and institutional guidelines in preparation for expedited and convened IRB review
- Review all complete project submissions, determine review type, recommend assignment of reviewers or ancillary review, and recommend exempt status
- Communicate to Principal 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 subject’s 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
Join our team TODAY! MEI Technologies is growing! MEIT since 1992 is a nationwide technology company that has implemented process-oriented management and has redefined itself into the family-owned organization that offers innovative, best-value services and solutions within four focused capabilities: Engineering Services & Solutions, Modeling and Simulation, Space Systems, Design & Integration; and IT/Cyber Services & Solutions. Why Choose MEIT?? At MEIT YOU WILL have the opportunity to collaborate with some of the brightest, most experienced engineering and technology experts in the U.S.!! - MEIT has established proven, quality work methods, including ISO, CMMI and AS9100 certifications.
- MEIT stands by delivering what we promise with flexibility, quality and integrity to our employees and our customers.
- MEIT reputation for entering a new market, getting to work and generating immediate and impactful results.
With an abundance of collaborative individuals MEIT is an organization that provides the opportunity to truly reach your potential as a professional. www.meitechinc.com MEIT is an Equal Opportunity Employer /M/F/disability/protected veteran employer. MEIT is a Woman-Owned Small Business (WOSB) serving government and commercial sectors across the United States. |