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· 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
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