Screening, enrolling the subjects and schedule study visits.
Assistance in resolving all queries that the monitor may bring to attention.
Completing e CRF with minimal errors.
Accurately reporting and tracking the adverse events. Maintaining Study master file of clinical studies.
Good knowledge of ICH, GCP guidelines, as provided during the investigator meeting and site initiation.
Ensuring the maintenance of protocols as per ICH/GCP requirement.
Maintenance of source file documentation and same being transfer to crf both paper and ecrf (MEDIDATA, INFORM and INET).
Involved in handling the INTERACTING VOICE RESPONSE SYSTEM by following the well-defined steps instructed by the system.
ECG Recording, transmission to the respective centre and maintaining the faxed and the original ECG report in respective subject file.
Well versed in documentation like submission, notification and approvals in time.