Job Description
Role: Clinical Research Associate/Scientist
Responsibility:
· Bioequivalence protocol preparation
· Monitoring the clinical study & ensuring it has been conducted according to the protocol, ICH-GCP and as per required regulatory guidelines
· Preparation of Study Master File
· Reporting of Adverse Event (AE) and Serious Adverse Event (SAE)
· To write and revise SOPs as per need and maintain awareness and adherence to all current SOPs
· Preparation and compilation of Case Record Form
· Compilation and analysis of raw data and its archiving
· Auditing the study
Good Knowledge of Pharmacokinetic, Pharmacodynamic, Bioavailability and Bioequivalence.
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