Program Manager Clinical Research

Job Summary:

Responsible for administration, oversight, management, implementation and accountability of clinical research, data collection activities and clinical operations for assigned research program. Coordinates project activities, regulatory approvals, contracting and is accountable for assigned research cost center budget. 

Essential Functions:

• Facilitates research activities in partnership with program Medical Director(s) and Research Administration colleagues leveraging clinical experience in related specialty area. Activities include coordination of grant submissions and sponsored clinical trials. Work includes management of site selection process, site initiation visits, and study submissions consistent with regulatory requirements and local policies.
• Directs, organizes and plans the daily research operational activities of the program and support staff to manage and grow the divisions research activities. 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, timely data collection and submission and related contract and/or grant goals) through regular reporting and coordinated discussions.
• Manages program budget working synergistically with Research Administration to perform and coordinate transactional tasks; i.e., sponsor invoicing, patient financial billing, time and effort reporting, etc. Proactively manages supplies, staffing needs and research portfolio via forecasting reports to ensure a robust study pipeline is in place. Acts as the program fiscal steward and works to promote and grow the research portfolio thru public relations, web-based activities, newsletters and social media outlets.
• A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies. Coordinates the process flow of a study from initial concept to IRB through the final study closure. Facilitates feasibility reviews based upon governing policies.

Education and Experience:

• Bachelors Of Nursing Required
• Masters in healthcare related or business field required.
• Minimum of five (5) years experience in related field.
• Three (3) years management experience.

Licensure:

• Registered Nurse: AZ or Compact
• Clinical Research Associate (CCRA) within 12 months of hire

Certification:

• Current CITI training certificate

Hello humankindness

Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services.  Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.

U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery.  In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.

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