This position supports the development, implementation and evaluation of human subjects research studies 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. Under the guidance of the Director or Research Ethics & Governance, this position coordinates the submission, review, and approval processes for studies requiring IRB approval. In addition, this position 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.
- Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
- Excellence in clinical care, service and communication
- Collaborative within our institution and with others who share our mission and goals
- Leadership that set the standard for pediatric health care today and innovations of the future
- Accountability to our patients, community and each other for providing the best in the most cost-effective way.
- Provides support with the planning, developing, implementing and evaluating 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.
- Coordinates review and approvals of research proposals by investigators through IRB and administrative procedures
- Supports the 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.
- Serves as a resource for research investigators regarding FDA/OHRP requirements/regulations and IRB submissions
- Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements; notifies appropriate individuals of potentially serious adverse effects, non-compliance, and/or logistically difficult projects.
- Performs miscellaneous job related duties as requested.