Senior Clinical Research Associate

3 days ago

กรงเทพมหานคร, Thailand AstraZeneca Full time

**About the job**

The Senior Clinical Research Associate has local responsibility for the delivery of the studies at allocated centers and is active in ensuring that quality and quantity commitments are achieved in a timely and efficient manner.

**Major responsibilities**
- Set up, initiated, monitored, closed and documentation archived of clinical studies
- Contribute to patient recruitment strategy including drive performance at the sites to meet study commitments.
- Proactively identify study-related issues, risk mitigation and escalates to the team.
- Update relevant systems with data from centres as per required timelines.
- Manage study drug and study supplies and drug accountability at study sites.
- Obtain and maintain essential documentation, Trial Master File in compliance with ICH-GCP, AZ SOP and local regulations
- Ensure accurate and timely reporting of Serious Adverse Events.
- Prepare for activities associated with audits and regulatory inspections
- Ensure compliance with AstraZeneca’s Code of Conduct, policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- 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
- Minimum 4-5 years experience in clinical trial monitoring
- Fluent knowledge of spoken, listened and written English.
- Good ability to learn and to adapt to work with IT systems
- Ability to travel nationally as required.

**Required Skills & Competencies**:

- Excellent knowledge/experience of Clinical Study Process, ICH/GCP and relevant local regulations
- Excellent ability to prioritize and handle multiple tasks.
- Excellent presentation and communication skills, verbal and written
- Excellent project management, analytical, decision-making and organisational skills.
- Excellent interpersonal skills
- Ability to deliver quality according to the requested standards.
- Ability to work in an environment of remote collaborators.
- Ability to use and develop computer skills

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