subhashree vellore selvaraj

•To work in all ICU’s (Medical, Surgical, Pediatric, Neonatal, Emergency, and Post-operative) of the Hospital. •Good Knowledge on ICH-GCP. •Prepares and maintains Site Master File (SMF). •Assisting CRA and active participation in study team discussions. •Patient recruitment. •CTMS: Data Collection, Data entry, Data Management (CRF). •Query resolution in consultation with local PI and CRA. •Monitor study activities to ensure compliance with study protocols and relevant institutional polices.

• Process clinical trial safety data within the established timeframe. • AERS database and Argus database. • Perform Triage, medical entry and quality review of AE and SAE of clinical trials, spontaneous cases ,Post-marketing, literature cases. • Case classifications (validity, seriousness, expectedness/listedness/labelledness) • Perform medical assessment, safety narrative writing (Regulatory Writing), MedDRA coding, E2B fields, PSUR and Risk assessment comments to comply with US-FDA.

• Identify the Study Participants. • Data Collection. • Patient recruitment. • Updating Database(MEDIDATA,RAVE) • Maintaining subject files and logs. • Recording information on Source documents. • Sample Processing. • Tracking of study documentation. • Drug Accountability, Drug Monitoring, Observing Adverse Events & Serious Adverse Events, Performing ECG and Holter.