Jwala Keshwar Rao K

Clinical Research Associate Iv @Axis Clinicals Ltd

Hyderabad, IN

Reviewing CRFs, Protocols, ICFs, TMFs, Agreements & Clinical study reports. Assist in Investigator Site Qualification, Study site selection, Vendor selection, Study start-up and Study site training. Tracking completed eCRFs and setting up systems whereby completed eCRFs are rapidly entered into the database. Ensure that data is provided in a timely manner for timely updation, analysis and query resolution. Ensure Subject safety, SAE and AE reporting to Sponsor and IRB/IEC. Conduct Close-out activities. Manage Subject recruitment, coordinate the movement of laboratory samples, timely shipment of IPs and trial supplies. Preparing and reviewing Monitoring SOPs, Monitoring tools for conducting Monitoring tasks including Monitoring plans, Monitoring reports, Corrective and Preventive action plans. Participate in Training sessions and SOP development. Monitoring the assigned clinical trial as per Protocol, SOPs, GCP and other regulatory requirements

ICRI

Ms Clinical Research

Kakatiya University

BSc Biotechnology