Remote IRB Program Manager — Regulatory Oversight Lead

Phoenix Children's Hospital, Inc.; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Phoenix Children's Hospital, Inc. is seeking a Senior IRB Administrator to supervise the development, implementation, and evaluation of clinical research trials, ensuring compliance with IRB policies and regulations.

The role coordinates resources and offers regulatory guidance to investigators and coordinators involved in human subjects research. The position involves interacting with OHRP and FDA, overseeing IRB operations, and training staff on regulatory requirements.

Qualifications

• Four (4) or more years of experience in human research protection administration.
• Experience with applicable federal and state guidelines and regulations.
• Four (4) or more years of experience as an IRB Coordinator.
• Certification in IRB Management (CIM) or Certified IRB Professional (CIP) OR eligible to sit for exam before employment start date.

Responsibilities

• Coordinates review and approvals of research proposals by investigators through IRB and administrative procedures to ensure compliance with all requirements.
• Interacts with the Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) and other governmental agencies regarding research regulations; prepares and participates in audits by the OHRP, FDA, or other governmental agencies.
• Oversees day-to-day functions of the IRB, including pre-review of all IRB documents; generates and distributes IRB agendas, meeting packets, minutes, and correspondence in an accurate and timely manner.
• Plans, develops and implements regulatory guideline training programs for physicians, coordinators and IRB members to ensure ongoing familiarity and understanding of applicable laws and requirements.
• Plans, develops, implements, and evaluates all IRB department policies, procedures, and processes; implements quality assurance in conjunction with the Office of Research to ensure compliance with IRB standards and federal/state requirements.
• Provides guidance to research investigators regarding FDA/OHRP requirements/regulations and IRB submission requirements.
• Provides oversight and mentorship to the IRB Coordinator.
• Reviews proposals and determines if they meet criteria for exemption under OHRP and FDA regulations.
• Reviews proposals and determines if they meet the OHRP/FDA definition of Human Subject Research.
• Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements; notifies appropriate individual of potentially serious adverse effects, non-compliance, and/or logistically difficult projects.
• Performs miscellaneous job related duties as requested.

Skills

IRB oversight

Regulatory compliance

Leadership

Education

Bachelor's degree in a related field

Job description

Phoenix Children's Hospital, Inc. is seeking a Senior IRB Administrator to supervise the development, implementation, and evaluation of clinical research trials, ensuring compliance with IRB policies and regulations.

The role coordinates resources and offers regulatory guidance to investigators and coordinators involved in human subjects research. The position involves interacting with OHRP and FDA, overseeing IRB operations, and training staff on regulatory requirements.