This position manages and guides, through operational oversight, the Hospital`s Office of Research Operations to ensure compliance with required federal, state, and all other applicable governing regulations, requirements, and standards. Manages the operational management of hospital research activities and programs including research policies and procedures, administrative management of the Institutional Review Board (IRB) and Scientific Review Committee (SRC). Responsible for on-going quality assurance to ensure Good Clinical Practice and adherence to FDA regulations.

1. Develops and provides orientation and training for new clinical research staff.
2. Develops and supervises staff through provision of timely feedback and use of appropriate Human Resource policies and tools to facilitate and ensure the ability of staff to achieve highest level of professional growth and desired performance standards.
3. Manages research projects by reviewing research study applications to ensure feasability of effort and coordination with all required resources/requirements for successful implementation.
4. Manages the completion of Standard Operating Procedures (SOPs) for each department performing research. Assists with the implementation of SOPs as needed for the Research Office/Institutional Review Board.
5. Manages the operational activities by guiding and supporting staff as well as acting as liaison with other areas to facilitate speedy resolution to issues.
6. Plans, develops, implements, and evaluates all department policies, procedures, and processes; implements quality assurance plans and conducts audits of clinical research activities to ensure compliance with funding source requirements, IRB standards, and federal/state requirements.
7. Plans, develops, implements, and evaluates regulatory guideline training programs for physicians and coordinators to ensure ongoing familiarity and understanding of applicable laws and requirements.
8. Provides operational oversight of research study processes to assure compliance with all federal, state, and regulatory agency requirements; notifies Director of Research Operations of potentially serious adverse effects, non-compliance and/or logistically difficult projects.
9. Reviews research study proposals for completeness and provides guidance to investigators and research staff regarding completion of appropriate regulatory study documents including budget documents.
10. Performs miscellaneous job related duties as requested.

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