หน้าที่ความรับผิดชอบ

The Clinical Research Associate (CRA) has responsibilities for the delivery of the studies at allocated centers and are active ensuring that quality and quantity commitments are achieved in a timely and efficient manner.

• Manage EC submission, Initiation, Monitoring and Closure of clinical studies
• Proactive to drive recruitment at study sites. Identify study-related issues and escalates to the team to ensure recruitment target is achieved with speed and quality.
• Obtain and maintain essential documentation, electronic Trial Master File in compliance with ICH-GCP, SOP and local regulations
• Update relevant systems with data from centers as per required timelines.
• Manage study drug and study supplies at study sites.
• Ensure accurate and timely reporting of Serious Adverse Events and other safety report.
• Prepare for activities associated with audits and regulatory inspections
• Collaboration with local team to contribute to process improvements, knowledge transfer and best practice sharing.