CRA for BE study/New drugs/Medical devices
1.Clinical research study setup/study procedure setup/site staff training
2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP
3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports
4.regular report to sponsor/communication between sponsor and site.
5.site close-out/trial materials retrieval
6.audits/regulatory inspection participation upon request
• Providing technical expertise/scientific input on formulation development
strategies
• Preparation and practical execution of formulation development projects
• Providing scientific expertise and formulation insights to Core Teams meetings
• Review test results in alignment with the project goals, identify causes of variances
and recommend solutions to achieve goals.
• Supporting the scale-up of developed formulations and bringing them to GMP
manufacturing
• Schedule experiments and prioritize assignments to meet project objectives and
deadline.
• Maintain laboratory equipment and chemicals in a safe manner.
• Responsible for writing up R&D documents and research reports.