Clinical Research Associate

Description

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.

Major responsibilities:

• 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.

Minimum Requirements and Preferred Background:

• Bachelor degree or higher, preferably with a pharmacy, nursing or medical related field
• 2 -3 years’ experience in clinical trial monitoring
• Fluent in English and Thai ( verbal and written).
• Ability to travel nationally as required.
• Excellent ability to prioritize and handle multiple tasks.
• Good presentation and communication skills, verbal and written
• Good project management, analytical, decision-making, organizational and interpersonal skills.
• Good computer skills and ability to learn and to adapt working with IT systems