Clinical Trial Coordinator
Current• IRB Submission - Initial submission - Amendment submission - IRB communications•TFDA submission - Initial submission - Amendment, CSR submission - TFDA communications • eTMF management • Office Based Clinical Trials Monitoring Study start up - CTMS, SIP, CLMS establishment - Investigator’s site file (ISF)/eISF preparation - Essential documents assessment Ongoing phase - CTMS, SIP maintenance - Site staff training (CLMS) management