El Zahraa Ismail

Clinical specialistFull Time

• Job Details:● Full literature survey about drugs and their active metabolites. ● Participate in the preparation of technical & financial quotations. ● Preparation of the study protocol. ● Management of investigation product samples in the drug store and recording in relevant sheets. ● Preparation of the trial master file of a clinical study. ● Preparation of ethics committee documents. ● Responsible for clinical study steps conduction. ● Performing full monitoring activities for BE studies and ensuring compliance with the applicable regulatory requirements pertaining to ICH,GCP and company's quality management system. ● Packing of plasma samples after each study phase. ● Dispensing Investigation products introduced to volunteers according to randomization sheet. ● Delivery of the drug sample to the laboratory. ● Sending emails whenever needs to ethics, sponsors (for any adverse event detetected). ● OpenClinica system E-CRF data entry, query resolving, and database lock data entry.

Community pharmacistPart Time