Clinical Research Associate (CRA) @ St.Jude Medicals, Delhi B10

Job Description

Job Title: Clinical Research Associate
Job Reports to following Title: Clinical Manager
Work Location: Delhi

Essential Functions:
• Overall management of assigned study centers
• Pre-trial activities (EC submissions), Site Training, Site Initiation & Monitoring
• Lead CRA for assigned projects
• Act as the main line of communication between the sponsor and the investigator
• Responsible for the safety and proper conduct throughout the trial

Other Duties:
• Medical writing: Protocol, CRF, study report, abstracts & manuscript writing
• Trial Master file preparation and maintenance for assigned projects
• Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
• Verifying that the investigator follows the approved protocol and all GCP procedures
• Verifying that source data/documents and other trial records are accurate, complete, and maintained
• Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
• Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator


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