Purpose

To perform activities in the preparation, initiation, monitoring and closure for an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. To ensure quality and quantity commitments are achieved in a timely manner.

Responsibilities

The Clinical Research Associate will

• Perform initiation, monitoring and closure of clinical studies in compliance with AZ Procedural Documents, ICH-GCP and local requirement
• Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site
• Manage study drug supplies, study drug accountability and study supplies at the study sites
• Track and manage agreed payments at study site level
• Train, support and advise Investigators and study site staff in study related matters
• Provide information on patient recruitment and study site progress within MC Study Delivery Team
• Update IMPACT with data from sites in a timely manner
• Ensure accurate and timely reporting of Serious Adverse Events
• Prepare for activities associated with audits and regulatory inspections in liaison with CQA.
• Contribute to process improvements: work with other team members to share knowledge, experience and best practices

Qualifications

Qualified candidates will be required to have

• Bachelor’s degree, preferably with a pharmacy or nursing
• 1- 2 years experience in clinical research monitoring
• Good knowledge of drug development process, clinical trial procedures, ICH-GCP and local requirement
• Proficient in oral and written communication (Thai and English)
• Proficient in the use of computer and soft ware systems

Functional Competencies

• Effective time management and project management
• Good decision-making skills and interpersonal skills
• Excellent ability to have attention to details
• Excellent ability in working according to global standards

 Leadership Competencies

• Passion for Customers
• Thinks Strategically
• Acts Decisively
• Drives Performance
• Works Collaboratively
• Develops People and Organization

If you are interested in joining our leading pharmaceutical team at AstraZeneca, please submit your full CV with recent photo including current and expected package by email or apply in person from Mon-Fri 8.00 – 17.00 hrs at:

Human Resources Department, AstraZeneca (Thailand) Ltd.
12th floor Phairojkijja Building, 400 Bangna-Trad road Km 4,
Bangna, Bangkok 10260, Thailand
Email: hrd.thbk@astrazeneca.com
Tel: 02 – 739 7410~3