Strategies to be a Successful Clinical Research Associate

Students or Working professionals taking this course would get detailed knowledge of who is a Clinical Research Associate, what are his responsibilities in various stages of Clinical development of a Drug/Device/Vaccine. A CRA is a Clinical research professional with Bachelors/Master's degree in any Life sciences who monitors a trial at the Trial Site. There are 4 stages in Clinical Development such as-1) Study Planning which involves working on Study design, Protocol development and Case report form Design and development. 2) Study Initiation which involves submitting various essentials document for IRB approval to trial site, Investigator selection, Initiating Investigator's meeting, Site Initiation visit, etc. 3) Study Monitoring which involves Preparing for a Monitoring visit, Monitoring plan which includes Serious Adverse event review, Informed consent review, Checking Protocol adherence, Case report form and Source document review, Investigational product accountability, Queries and error correction, Review of Investigator study file.  Monitoring visit also involves completion of Monitoring visit report. 4) Study Close-out includes addressing items such as Case report forms, Drug accountability, Investigator's study file, Investigator's final report to Sponsor and IRB, Administrative issues and Final Visit report.

This course also highlights importance of CRA in training site for Informed consent process and documentation and Adverse event reporting.