Clinical Trial Assistant Jobs in Bangalore - G7 Ssynergon Pvt Ltd

·      To read and understand SOPs and procedures related to the task allotted by the Manager/Designee

·      To understand and complete the training on the assigned study specific trial related documents 

·      Assist the study monitor in EC Dossier preparation as per the requirement of respective EC for all the assigned studies

·      Involved in preparation and shipment of Investigator site file, pharmacy file, CRFs and other clinical study documents to the site as per the study specific timelines

·      Assist the monitors in preparation and conduct of site selection, site initiation, site interim and site closeout monitoring visits

·      Maintain records for clinical study material supplies (consisting of laboratory kits, investigational product where applicable and any other study specific supplies), including the tracking and shipment of materials as appropriate

·      Review and update the project specific files as per study specific timelines

·      Coordinate with the assigned study site to collect the missing documents in project file and send the missing documents which required to be filed at investigational site

·      Raising requests to QA for obtaining necessary controlled documents

·      Raising requests for archiving the documents after the study closure

·      Update and maintain study progress tracking/Project trackers in accordance with the demand of the study requirements e.g. investigational product tracking, CRF tracking, patient tracking, etc.,

·      Coordinate with Clinical Head/Project Manager/designee for conducting the training at G7 Synergon

·      Perform other study/departmental activities as assigned by Clinical Head/Project Manager

Qualification: B. Pharm, M. Pharm