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 Pre-Award Program Manager is responsible for the analysis, negotiation, and finalization of arrangements for research in compliance with all applicable laws and regulations. Additionally, this position is responsible to ensure quality research coverage analysis reviews are performed for all research proposals to identify items and services that are not billable to a third party payor and negotiate Sponsor payment for non-billable services.
The Pre-Award Program Manager oversees the workflow and assignment for all Research Contracts Specialist(s) and/or contracting agencies to ensure timely contract reviews, budget development and negotiation and execution of billing grids for post-award processing consistent with institutional goals. This position performs and oversees contract negotiation to secure favorable terms and conditions for all research transactions. This position works closely with Dignity Health legal counsel, serving as the primary point of contact for escalation of contract matters to counsel as needed and promotes terms and conditions to mitigate risk and support obligation management. This position implements and oversees research policies, procedures, and templates for the institution upon approval from Dignity Health Legal Department.
This position requires innovation and creative problem solving as well as effective verbal and written communication and a high level of innovative and interpersonal skills to interact with Sponsors, Investigators, colleagues, facility administrators and patient financial services. Using extensive knowledge of billing rules and regulations as well as federal, state and local laws related to research, this position serves as an expert in project feasibility reviews and risk mitigation working synergistically with Dignity Health Legal Department.
This position is responsible for the management of all research contract and budget negotiations with an understanding of institutional risk tolerance and research financial policies to engage leadership in business decisions key to the approval of research projects and management of the research portfolio.
One year of experience with clinical trials/clinical research contracts. Knowledge of regulations applicable to research. Must be able to work with minimal supervision and prioritize multiple projects.
Paralegal certificate with 5 years of experience in research contracting, OR Bachelor’s degree with 3 years of job-related healthcare contracting experience required.
Strong ability to build collegial relationships. Superior knowledge of GLP, ICH, DHHS, OIG and FDA regulations. Self-directed, with the ability to develop project plans from conceptualization to implementation in an efficient and cost-effective manner. Refined professional writing and communication skills. Ability to work effectively with internal administration, internal departments, and investigators as well as professional finesse to build relationships with sponsors and funding agencies to manage post-award contract obligations.
Three years of practical experience in clinical trials/clinical research contracts and research budget/billing operations within a large academic health system. Candidates with knowledge and/or experience with government assistance and acquisition contracting are preferred
Bachelor’s degree, Post-graduate degree, paralegal certificate or JD from an accredited law school with prior experience in research and/or healthcare administration.
Current CITI training certificate.
Proven attention to detail with strong analytical, critical thinking, problem solving, time management and customer service skills. Excellent computer skills and the ability to utilize automated systems. Strong interpersonal skills to effectively navigate a matrix organizational structure and effectively contribute to cross-functional teams regardless of reporting structures.
Research Society certification or ability to obtain within 24 months of employment.
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