Responsible for assigned clinical trials including clinical trial preparation, clinical trial implementation, study monitoring, unblinded monitoring, and clinical site closure.
- Manage IP-related activities (import license submission, maintain IP storage room, dispensing, release IP for study site, IP handling, audit, inspection).
- Develop randomization for BE & Clinical Trial.
- Receive IP and check consistency data of IP (physically, IP receiving form, protocol).
- Check and confirm data logger for IP shipment.
- Clinical site application submission to Ethical committee and Regulatory Authority, Ministry of Health.
- Assist Clinical Project Manager on site feasibility, investigator selection, and site set up.
- Assist Clinical Project Manager on managing timeline and operational study from study start-up until study closure.
- Monitoring clinical trial implementation on site.
- Unblinded monitor for clinical trial in site.
- Maintaining trial documentation.
- Acting as a communication line between investigator and sponsor.
- Manage clinical trial data and support the development of the study reports.
- Responsible for other additional / special task that assigned by the superior manager.
- Bachelor Degree from Pharmacy or Science.
- At least 1 year experience as the CRA, Regulatory/Registration in Pharmaceutical Companies, Clinical Research Industry or Hospital.
- Independent, detail and high compliance.
- Having good communication and negotiation skills.
- English proficiency is preferably.