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Detail posisi

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

Kewajiban

• 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.

Kualifikasi

• Bachelor degree or higher, preferably with a pharmacy, nursing or medical related field.
• 1-3 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.

Keuntungan