CRA

CRA

Purpose 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 study
Identify, select, and monitor performance of investigational sites for clinical studies
Perform clinical data review of data listings and summary tables to assure the quality at site and the provision of clean data
Ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate as appropriate
Overall coordination of clinical trials from design to closeout and reporting.
To be fully aware of the Sponsor’s Study requirements
To be fully aware of ICH GCP and country regulatory requirements