The Manager, Research Ethics/Human Subjects Protection Program (HRPP) has managerial and operational oversight of organizational regulatory, research ethics, the Institutional Review Boards (IRB), Research Compliance and Conflicts of Interest Committee (RCC), Research Credentialing, and the Scientific Review Panel (SRP). He/She functions as a regulatory and research policy resource/expert for research faculty and staff. In addition, this position also works closely with the Director of Research Operations, SVP Research and organizational leadership for the coordination and stimulation of research and knowledge development initiatives. This position will facilitate, foster, and grow collaborations to achieve the short and long-term research goals for Phoenix Children’s.

1. Oversees and coordinates HRPP activities including the Scientific Review Committee, oversight of offices and staff that have roles in protecting human research subjects, research credentialing, monitoring of approved research studies, education and training, policy development, and IRB operations. Liaise with the Office of Research, research compliance and internal audit representatives as appropriate.
2. Oversees and ensures employee engagement, adequate staffing levels, HRPP budget development and compliance. Responsible for staffing decisions such as hiring of competent and qualified individuals, terminating employment, mentoring, and counseling employees on work-related performance.
3. Stays current with changing regulatory guideline Develops and maintains written operational policies and procedures for the HRPP that are consistent with current regulatory guidelines and communicate pertinent information to staff in a timely and accessible manner. Coordinates appropriate activities with the Office of Compliance and Privacy.
4. Serves as the human subjects protection officer/ethics officer for Phoenix Children’s. Primary institutional liaison for state and federal regulatory oversight bodies (e.g. NIH OHRP, FDA, AZDH) and maintains institutional assurances and regulatory reports.
5. Assists the Director, Clinical Research Operations & SVP Research with the development of short and long term strategies to improve the research support needs of investigators at Phoenix Children’s.
6. Develop metrics and regular reporting for workload volume and review timelines, as well as other reports as requested; align to industry best practices.
7. Assists the Director, Clinical Research Operations & SVP Research with identifying research areas with high probability of external funding. Maintains high quality, responsive, collegial, and trustworthy relationships with internal and external stakeholders supporting research at Phoenix Children’s.
8. Develops programs to stimulate synergistic interactions among institute scientists and affiliated external organizations.
9. Responsible for maintaining AAHRPP certification requirements.
10. Oversees sponsored project processes to assure compliance with all federal, state, and regulatory agency requirements; notifies SVP Research of potentially serious adverse effects, non-compliance, and/or logistically difficult projects.
11. Responsible for reviewing and evaluating conflicts of interests and developing management plans where necessary with the VP of Compliance and Office of Business Integrity.
12. 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