Research Associate

Issuing controlled/ documents, and other approved uncontrolled/usage copies of SOPs, forms/formats/logbooks, study documents of CRO. To check that correct documents are issued before issuing the same. To update and maintain the master document file. Issuing and compiling deviation forms and maintaining log. Issuing and compiling change control forms and maintaining log. To review data submitted by quality control department related to BA/BE study - Before study, during study and after completion of study. on-line phase monitoring of Bio-study To carry out system based audit of BA/BE/ CT and BA department at CRO. Verification of the files, logbooks, submitted for archival. Maintenance and updation of Quality Manual CRO Master File. Review of validation/ calibration maintenance of equipment s and software. Handling of sponsor audit, queries resolution and response of sponsor queries audit report. Ensuring updation of CRO procedure and SOPs according to current regulatory, guidelines.