IRB Program Manager

IRB Program Manager
Department: RSRCH-GRNT | Clinical Research Admin
Location: Telecommuting
Shift: Mon-Fri, Days, 8am-5pm
Category: Research
Posting #: 1066705
Employee Type: Full-Time
Position Summary
This position supervises the development, implementation, and evaluation of clinical research trials to ensure consistency with all IRB policies and procedures; coordinates resource requirement and utilization to ensure compliance with required federal, state, funding source, and all other applicable governing regulations, requirements, and standards. This position also provides regulatory, ethical and methodological guidance to investigators and coordinators to prepare applications for research proposals involving human subjects and provides consultation to IRB members and institutional officials regarding federal regulations and institutional policy.
Position Duties
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 (as necessary) 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.
Phoenix Children's Mission, Vision, & Values
Mission
To advance hope, healing and the best healthcare for children and their families
Vision
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
Values
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

Work arrangement
Yes