Clinical Research Associate

Responsibilities

• Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study.
• Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time.
• Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.
• Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trail end.
• Ensuring EDC/CTMS system is updated in a timely and accurate manner in accordance with requirements.
• Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP.
• Update investigator file and trial master file.
• Build and maintain positive relationships with the site and investigators.
• Ensure site visit reports and correspondence ...