Clinical research associate/ clinical research or trial monitor- a career path

Abstract

where different research activities are supported by the sponsor of the research or Clinical Research Organization that takes contracts from different sponsors. The role of CRA is to ensure that clinical research / trials are conducted in accordance with Standard Operating Procedures (SOP) and International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. The CRA has the responsibility to verify that the rights and well being of human subjects are protected and that the reported trial data are accurate, complete and verifiable from the source documents and/ or patient charts. The CRA also has to ensure that the trial is in compliance with the most recently approved protocol.