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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Develop metrics and regular reporting for workload volume and review timelines, as well as other reports as requested; align to industry best practices.
- 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.
- Develops programs to stimulate synergistic interactions among institute scientists and affiliated external organizations.
- Responsible for maintaining AAHRPP certification requirements.
- 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.
- Responsible for reviewing and evaluating conflicts of interests and developing management plans where necessary with the VP of Compliance and Office of Business Integrity.
- Performs miscellaneous job related duties as requested.