临床监查员cra(长沙) - Changsha, Hunan

Job summary

The Clinical Research Associate CRA will contribute comments/input in the development of Protocol Informed Consent Form ICF Case Report Forms CRF and other project related documents Evaluation potential sites with the assistance from the senior CRA PM or line manager provide PM with recommendations for selection of qualified sites Prepare the package for institutional review boards IRB and local regulatory authority submissions obtain IRB/regulatory approvals for conducting the clinical trial Assist PM in start-up meeting Prepare and manage clinical trial agreements with investigators/sites Track manage and control site budget expenses within approved budget in line with project milestones as requested Managecoordinate investigational products clinical trial materials at sites compliance regulatory requirements Monitor report project status at sites timely manner Key contact person communication between sites study team Prepare arrange conduct training site personnel Conduct site initiation monitoring closeout visits compliance monitoring plan ICHGCP SOPs local regulations applicable projectspecific plans Prepare monitoring report according to SOP Assist investigator auditinginspection project Coordinate ensure all adverse events followup appropriately reported reconciled regulations Identify analyze resolve issues investigator sites

工作描述