Manager Research Operations

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. Look for us on Facebook and follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

As our Manager, Research Operations, you will manage and supervise clinical research staff, ensuring the successful and timely completion of clinical trials and full compliance with all relevant regulations.

Every day you will coordinate and monitor all clinical research operational activities, managing trials according to regulations and ICH-GCP guidelines. You will also assist with research approvals, oversee study budgets, manage enrollment/performance, forecast resources, and develop/standardize clinical research policies and procedures.

To be successful in this role, you will demonstrate exceptional leadership in clinical research, expertise in regulatory compliance, and a proven ability to manage complex resources and processes to ensure high-quality, compliant trial execution.

• Participates in the planning, performance and management of all clinical trials in compliance with applicable regulations, ICH-GCP guidelines and internal policies. Acts as an administrative resource helping clinicians and other investigators navigate human subjects research approval processes.
• Coordinates and monitors activities of all clinical research operational staff to ensure successful and timely completion of clinical trials. Works also, and when relevant, with program manager(s), to effectively forecast and manage trials financial performance, including nurse and coordinator assignments.
• Collaborates with legal and IP office as necessary in overseeing and approving study budgets and with staff and billing service units to ensure proper allocation of funds to cover expenses specific to trials activity. Monitors enrollment and study performance based upon contract deliverables and works to effectively forecast resource needs to ensure solid performance.
• Organizes clinical research staff orientation and education offerings and actively participates in learning relating to role. Works to develop standardized working instructions across all programs, and develops all clinical research operations policies and procedures. Develops mechanisms to ensure annual reviews of policies are in place. Monitors research activities to ensure compliance with federal, state and local regulations and guidelines.

Required

• Bachelors Other or a combination of education and/or job related experience.
• Minimum of eight (8) years of clinical research experience with a minimum of five (5) years of clinical research management, upon hire