Manager Research Operations

CommonSpirit HealthPhoenix, AZ
Onsite

About The Position

St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital located in Phoenix, Arizona, dedicated to caring for the poor and underserved. It is a nationally recognized center for quality quaternary care, medical education, and research, housing renowned institutes like the Barrow Neurological Institute and the Cancer Center at St. Joseph's. The hospital is also known for its high-risk obstetrics, neuro-rehabilitation, and orthopedics services, attracting complex cases from around the world. St. Joseph's is consistently ranked among the top hospitals in the U.S. for neurology and neurosurgery and is recognized as an outstanding place to work.

Requirements

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

Responsibilities

  • Manage and supervise clinical research staff, ensuring the successful and timely completion of clinical trials and full compliance with all relevant regulations.
  • Coordinate and monitor all clinical research operational activities, managing trials according to regulations and ICH-GCP guidelines.
  • Assist with research approvals, oversee study budgets, manage enrollment/performance, forecast resources, and develop/standardize clinical research policies and procedures.
  • Participate in the planning, performance, and management of all clinical trials in compliance with applicable regulations, ICH-GCP guidelines, and internal policies.
  • Act as an administrative resource helping clinicians and other investigators navigate human subjects research approval processes.
  • Coordinate and monitor activities of all clinical research operational staff to ensure successful and timely completion of clinical trials.
  • Effectively forecast and manage trials financial performance, including nurse and coordinator assignments.
  • Collaborate 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.
  • Monitor enrollment and study performance based upon contract deliverables and work to effectively forecast resource needs to ensure solid performance.
  • Organize clinical research staff orientation and education offerings and actively participate in learning relating to role.
  • Develop standardized working instructions across all programs, and develop all clinical research operations policies and procedures.
  • Develop mechanisms to ensure annual reviews of policies are in place.
  • Monitor research activities to ensure compliance with federal, state, and local regulations and guidelines.
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