Amy began her career in the labs at the University of Tennessee Center for Health Sciences and then managed the consumer products testing lab for a company that is now part of Merck.
Amy has over 30 years of research experience to include drugs and devices, consumer testing, and basic science. She works closely with the grant Principal Investigators, the NIH Program Office, and the DCOC Quality Program to ensure quality deliverables and adherence to protocol requirements, study operational plans, timelines, ICH GCP, and applicable SOPs. Program serves as the Program Director for the Data Coordinating Operations Center (DCOC), directing DCOC staff who manage the operational aspects of trials from start-up to final reporting. Her leadership also includes overseeing the clinical trials training programs, including curriculum and materials development, instruction, and participation in assessment plans. She supervises the Associate Director for Quality and oversees the DCOC quality program approves and develops internal and external ECHO ISPCTN and DCOC communications, and coordinates Network activities with the ECHO Program Office and Coordinating Center. This includes clinical operations, IRB and regulatory issues, safety operations, budgetary oversight, and training.
#Child study center uams trial#
As co- Principal Investigator of the IDeA States Pediatric Clinical Trial Network Data Coordinating and Operations Center (DCOC), she is responsible for directing clinical operations for trial implementation and professional development and provides strategic leadership for the DCOC to include overseeing clinical trial activities for all ECHO ISPCTN trials. She also has an active, NIH-funded basic science laboratory studying the role of age on the immune responses and neurologic outcomes following infections in the brain. Cabe Endowed Chair in Pediatric Infectious Disease. She is the Vice Chair for Research in the Department of Pediatrics, Associate Director of Clinical and Translational Research at Arkansas Children’s Research Institute, and holds the Horace C. Principal Investigator, Snowden is an Associate Professor of Pediatrics and Chief of the Division of Pediatric Infectious Disease at the University of Arkansas for Medical Sciences. Lee leads the NIH/NCI/UCLA AIDS Associated Malignancies Clinical Trials Consortium (AMC) as the Statistical Center Director and is actively involved as a peer mentor, reviewer, and is a member of several national committees focused on medical research. In addition to the activities of the ISPCTN, Dr. She interacts with collaborating clinical trials groups such as the Neonatal Research Network, participates in the protocol concept review process assesses opportunities for collaboration with other networks and works with the NIH in prioritizing studies. Lee interfaces with NIH, the Data Safety and Monitoring Board, and Protocol Review Committee and she provides input into the Clinical Trials Skills Knowledge Core. She oversees statistical design, sample size estimation, and analytic plans as well as overview of financial management of capitation funds.
She is a co-Principal Investigator of the IDeA States Pediatric Clinical Trial Network’s Data Coordinating and Operations Center (DCOC) with overall responsibility for the operations of the DCOC. Principal Investigator, Lee is a Professor in the Department of Biostatistics in the College of Medicine at the University of Arkansas for Medical Sciences.
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