Responsible to supporting Pharmacist for administrative activities of IP-related activities and ensure the activities in accordance with GCP requirements.
- Support the Pharmacist in administrative and operational activities related to Investigational Product (IP) and ensuring compliance with Good Clinical Practice (GCP) guidelines.
- Maintaining IP-related activities (import license submission, maintain IP storage room, dispensing, release IP for study site, IP handling, audit, inspection).
- Maintain documentation and records related to IP-related activities (randomization, logbook, form, daily checklist).
- Receive IP and check consistency data of IP (physically, IP receiving form, protocol).
- Check and confirm datalogger for IP shipment and send back IP or datalogger to sponsor.
- Destroy dispensed packaging, IP.
- Responsible for other additional / special task that assigned by the superior manager.
- Bachelor Degree from Pharmacy or Science.
- At least 1 year experience in Pharmaceutical Companies, Clinical Research Industry or Hospital.
- Independent, detail and high compliance.
- English proficiency is preferably.