Experienced Clinical Research Professional with over 10 years of experience conducting Phase I-III Clinical Trials in the areas of Oncology, Infectious Disease and Central Nervous System with 7 years of monitoring experience. Ability to design, implement and ensure the following of protocols. Experience in assisting and monitoring trials. Complete knowledge of GCP, ICH and FDA guidelines to include basic understanding of regulatory requirements. Current Workload: 3 Oncology studies with 14 sites. Knowledgeable of RECIST measurement criteria for solid tumors. Proficient with CTMS (Impact Harmony). Proficient with various EDC systems (i-Medidata, RAVE).