CRA

CRAPurpose of Job:Core monitoring role, with advanced responsibilities, critical and central to the conduct of the clinical project. The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.Job components:To monitor the proper conduct, documentation and progress of the studyIdentify, select, and monitor performance of investigational sites for clinical studiesPerform clinical data review of data listings and summary tables to assure the quality at site and the provision of clean dataEnsure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate as appropriateOverall coordination of clinical trials from design to closeout and reporting.To be fully aware of the Sponsor’s Study requirementsTo be fully aware of ICH GCP and country regulatory requirements