Clinical Research Associate
6 days ago
The Clinical Research Associate (CRA) is responsible for delivering the studies at allocated centers and actively ensures 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 escalate to the team to ensure the 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 reports.
- 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's 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
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