Greetings from Kairos Consultancy!!! It was a pleasure to be in touch with you.One of our reputed clint company based on Clinical reaserch is looking for Clinical Research Associate.
Clinical Research Associate
Ahmadabad (S.G. Highway)
Roles and Responsibilities
· Handling of Investigational product at clinical site
· Documents issuance from QMS
· Communications with hospital for emergency management and caterer for meal order
· Training of research team and to ensure that the research team are adequately trained for protocol and they have been delegated by investigator before performing any project specific activity
· Verifying that the research team follows the approved protocol and amendments(s) if any and SOP
· Ensure that all the study documents are accurate, complete, timely and legible and Data entered on to the CRFs is consistent with source data and submitted to QA/QC at stipulated time line
· Monitoring during study and documentation handling to ensure that all data are reliable and have been processed correctly
· To ensure that “AE/SAE, concomitant medication, Deviations, Note to files” are documented and reported appropriately to PM department as applicable within the time periods to report to EC/Sponsor/Regulatory
· Taking appropriate action designed to prevent recurrence of the detected deviations
Site preparation for the study and Ensuring the enrollment of eligible volunteers
Biological Sample Shipment.
Routine and non routine maintenance of equipments at clinical site
To generate and maintain Trial Master File for BA/BE & Clinical trials projects.
To work according to the application guidelines and applicable Synchron’s SOP
To take the guidance from reporting authority as and when required
Offered Salary2.00 Lacs