Located in the heart of Phoenix, Ariz., St. Joseph's Hospital and Medical Center is a 586-bed, not-for-profit hospital that provides a wide range of health, social and support services with special advocacy for the poor and underserved. St. Joseph's is a nationally recognized center for quality tertiary care, medical education and research. It includes the internationally renowned Barrow Neurological Institute, the Muhammad Ali Parkinson Center, the Norton Thoracic Institute, a campus of Creighton University's Medical School and the first Level I Trauma Center in Arizona verified by the American College of Surgeons. U.S. News & World Report routinely ranks St. Joseph's among the best hospitals in the United States for neurology and neurosurgery. For more information please visit our website at https://www.dignityhealth.org/arizona/locations/stjosephs.
The Program Manager for Clinical Research and Quality Improvement, Epilepsy Division, works closely with the clinical leadership to develop, implement, and coordinate effective systems to evaluate and improve patient outcomes and quality of care; build a strong QI team; coordinate inter-disciplinary patient care initiatives for the service line; perform community outreach to local neurologists and hospital systems; manage program finances; implement clinical trials and clinical research; facilitate research, academic, and industry collaborations; and secure extramural funding and philanthropy. This position acts as the primary Program Manager for the Epilepsy Division and reports jointly to the Clinical Research Operations Manager and the Epilepsy Medical Director while working collaboratively with other key internal BNI departments. A strong working knowledge of project management and/or quality improvement methodology, as well as GCP, DHHS, FDA and OIG regulations is required along with any and all applicable federal and state regulations and institutional policies.
*Works with Epilepsy Medical Director to design a quality improvement project portfolio to meet BNI’s strategic plan, Epilepsy Division performance goals, and AAN/NAEC/ELHS quality metrics.
*Utilizes project management and change management tools to help the multidisciplinary epilepsy team (physicians, APPs, nurses, EEG techs, other healthcare providers, and patient and family members) improve the health outcomes for epilepsy patients. Utilizes the Institute for Healthcare Improvement (IHI) model for quality improvement to build a strong QI team. Leads/Supervises team of highly skilled research professionals focused on clinical research and quality improvement program activities.
*Collaborates with clinicians and the (Epilepsy Learning Healthcare System) ELHS collaborators to present and publish quality improvement work.
*Provides coordination and support for clinical study and quality improvement data management to internal and external Epilepsy research teams.
*Directs Epilepsy community outreach program as guided by the Medical Director(s). Outreach may include meeting with area neurologists and hospital personnel, epilepsy advocacy organizations, public relations, web-based activities, newsletters and social media.
*Facilitates Epilepsy patient-based research in partnership with Medical Director(s) and Research Administration colleagues, including coordination of grant submissions and clinical trial contracting activities, monitoring of accounting unit budgets, FDA and IRB regulatory submissions, protocol designs, and annual reports.
*Directs, organizes and plans the daily research operational activities of the Epilepsy Research Program staff to support clinical trials and observational research. Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics) through regular reporting and coordinated discussions.
*Manages program budget working synergistically with Research Administrative resources to perform transactional tasks; i.e., sponsor invoicing, patient financial billing, services, and management, etc. Proactively manages supplies and staffing needs and develops tools to forecast resource ratios for fiscal stewardship of program.
*Guides and facilitates relationships with funding agencies and industry partners in support of Epilepsy research. Solid knowledge and interpretation of clinical trial compliance regulations and policies to manage relationships and support program growth within a compliant environment.
*Serves as a central negotiator and liaison between the institution, investigator, funding agencies, and contract entities; initiates requests for contract reviews, drafts and/or approves formal responses to requests for proposals on behalf of investigator.
*Assists with overall compliance with the principles of good clinical practices for Epilepsy research, including assistance and preparation of regulatory documents in coordination with Regulatory Affairs Coordinators to submit to IRB of records. Coordinates and prepares necessary documents for sponsor monitoring visit and works proactively to resolve any areas of discrepancy in a timely fashion.
*Performs miscellaneous job-related duties as assigned.
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