I am working as a clinical trial coordinator on oncology clinical trials ranging from phase I to phase III predominantly in breast & gynecological cancer
My typical day at TMH(Tata memorial hospital) starts with patient visit.I do patient screening, patient assessment ,patient examination,investigational product administration.
Adverse event assessment & reporting
Serious adverse event narrative writing & reporting to sponsor,ethics committee & regulatory authority into given time line.
CRF & eCRF completion in given time line.
Maintainance of site master file. Coordination with sponsor & EC for regulatory submissions with adherence to time line.Management of investigational product.
Preparing site for audits & inspections.
Review & preparation of CRFs. ICFs & protocol for intramural trials.