หน้าที่ความรับผิดชอบ

• Communicate and cooperate with clinical research unit, sponsor, ethical institutions and regulatory agencies.
• Design the bioequivalence study and prepare the study synopsis.
• Prepare and submit the study protocol and relevant documents for ethical approval.
• Draft the bioequivalence study report.
• Prepare the documentation for explanation of FDA or regulatory agencies' queries.
• Observe and investigate the clinical study procedures of clinical research unit as requested by sponsor.