Job Description :
- Prepare clinical study documents (protocol, CRF, informed consent form, etc.)
- Assist Principal Investigator for Ethics Committee submission
- Responsible for Regulatory Affairs submission
- Perform site feasibility, investigator selection, and site set up
- Perform clinical trial monitoring, follow up and discussion with study site team
- Responsible for maintaining trial documentation
- Acting as a communication line between investigator and sponsor
Qualifications:
- 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
- Open & flexible to travel
Laporkan lowongan
