Lashawn Stewart

Background

About Lashawn Stewart

Experienced Clinical Research Professional with over 7 years of monitoring experience. With an in depth understanding of complex compliance issues. Experienced in providing operations analysis focused on regulatory compliance, responsible for the planning, follow-up, and continuous improvement clinical services. Excellent knowledge of complete aspects of the clinical trials Ability to design, implement, and ensure following of trial protocols Experience in assisting and monitoring trials Focused with excellent attention to details Complete knowledge of GCP, ICH and FDA guidelines including basic understanding of regulatory requirements Adaptability Proficient in performing clinical data review by verifying source documents Proficient in Risk based monitoring, on-site monitoring, and remote in therapeutic areas of CNS and Cardiovascular. Proficient in identifying, reporting and assisting clinical sites with appropriately resolving protocol deviations. Knowledgeable of RECIST 1.1 and irRECIST measurement criteria for solid tumors Competent in various EDC systems (Medidata Rave, Oracle, InForm and Clinical/Remote Data Capture Proficient with CTMS (Impact Harmony, Siebel, and Trial Tracker)