I have total of five years of experience as Clinical Research Coordinator (Quality Control) in different hospitals across India. I am also familiar with the protocols, and study standards, guidelines, study documentation for safety management. Having an extensive experience in handling adverse events. Proficiency in the analysis and generation of reports, review of SOPs, Periodic Surveillance Report Forms (PSRFs), Literature search, Query response letter, CAPA report review. Good knowledge of the regulatory guidelines such as ISO, ICH, J-GCP & ICH etc