This position independently applies knowledge of OHRP/FDA human subject research and IRB regulations to coordinate review and approval of IRB submissions (including coordinating board meetings). Under the guidance of HRPP leadership, this position provides regulatory, ethical, and methodological support to investigators and study staff.

• Coordinates review and approvals of research submissions through IRB and administrative procedures to ensure compliance with all requirements.
  
  Independently understands and applies federal regulations for human subject research to all IRB submissions. Conducts submission pre-review, ensuring compliance with all federal, state, and local institutional requirements. Coordinates review and approvals of research submissions through IRB and administrative procedures to ensure compliance with all requirements. Notifies HRPP leadership of potentially serious adverse effects, non-compliance, and/or logistically difficult projects
• Oversee Board meetings
  
  Independently oversees Board meetings, including assigning reviews to staff and Board members, obtaining/maintaining quorum for the meeting, providing regulatory guidance at the meeting, and writing minutes and determination letters. Serve as an IRB member and exercise delegated IRB Chair signature authority to conduct expedited determinations on behalf of the IRB.
• Provides guidance to investigators regarding FDA/OHRP and acts as liaison between the IRB and the research community.
  
  Provides guidance to investigators regarding FDA/OHRP regulations and IRB submission requirements. Acts as a liaison between the IRB and the research community and responds to queries regarding IRB submissions and IRB software. Provides regulatory and ethical consults for investigators and research personnel on human subject research related issues. Gives presentations to IRB staff, Board members, and the research community. Assist with departmental projects, cross-departmental initiatives, and training and education.
• Quality Assurance & Compliance
  
  Works with IRB leadership to (a) develop and present educational initiatives for the research community, (b) review and update policies and procedures, and (c) carries out quality assurance to ensure compliance with local IRB policies and federal/state requirements.
• Performs miscellaneous job related duties as requested.
  

To advance hope, healing and the best healthcare for children and their families

Phoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.

We realize this vision by:

• Offering the most comprehensive care across ages, communities and specialties
• Investing in innovative research, including emerging treatments, tools and technologies
• Advancing education and training to shape the next generation of clinical leaders
• Advocating for the health and well-being of children and families

• We place children and families at the center of all we do
• We deliver exceptional care, every day and in every way
• We collaborate with colleagues, partners and communities to amplify our impact
• We set the standards of pediatric healthcare today, and innovate for the future
• We are accountable for making the highest quality care accessible and affordable