Phoenix Children’s Hospital has provided hope, healing, and the best healthcare for children since it was born in 1983, and it has grown to become one of the largest children’s hospitals in the country and it is Arizona’s only hospital dedicated to children. The hospital is home to the state’s largest group of pediatric specialists and sub-specialists providing the best care to the sickest kids. Phoenix Children’s continues to evolve its world-class care and is working with leading local and national research partners to uncover new breakthroughs in pediatric medicine. With a Medical Staff of nearly 1,000 pediatric specialists, Phoenix Children’s provides inpatient, outpatient, trauma and emergency care across more than 70 pediatric subspecialties, the most comprehensive pediatric care available in the state. The Hospital’s six Centers of Excellence include Barrow Neurological Institute at Phoenix Children’s Hospital; Phoenix Children’s Heart Center; Center for Pediatric Orthopedics; Center for Cancer and Blood Disorders; Level One Pediatric Trauma Center and Neonatal Intensive Care and these have grown in size and expertise since its inception.
Phoenix Children’s Hospital is seeking a Clinical Trials Compliance Auditor to join our team of professionals.
This position is responsible for conducting comprehensive research audits and monitoring of clinical trials to ensure faculty, staff, employees and students engaged in research activities are compliant with all aspects of federal, state and local policies and regulations governing clinical research. This position reviews internal regulatory documentation, protocols, amendments, correspondence, case report forms, study data, research billing reports, and adverse event reports.
- Bachelor's Degree in a related field (Required)
- Masters Degree in a related field (Preferred)
- Five (5) or more years of clinical research experience (Required)
- Two (2) or more years of clinical trials auditing/monitoring experience (Required)
- Industry-recognized certification (i.e., CCRC, CCRA, CCRP) (Required)
- GCP and human subjects protection training (Required)
- Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines (Required)
- Knowledge of IRB and federal regulations as they pertain to human subject research and the ability to interpret and apply laws and regulations to ensure the overall protection of human participants (Required)
- Project management skills, including the ability to identify needs, develop action plans, and manage projects to completion. Ability to multitask and to work efficiently and independently (Required)
- Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care (Required)
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