Good communication skills (written & verbal).
Hardcore monitoring experience in Clinical Trials
*Perform source document verification as per monitoring plan and ensure the source documents and other trial records are accurate, complete, kept up-to-date and maintained according to applicable SOP's to ensure complete records for example; Review of screening records, subject inclusion/exclusion criteria, and Informed Consent Forms, drug accountability records, Site Investigator File/ Trial Master File etc.
*Conduct monitoring of study activities as per monitoring plan
*Conduct Study close out visit: review of source documents/CRF, TMF, drug accountability
*Assist in preparation of Monitoring report writing and close looping of report.
*Establish and maintain primary communication with clinical sites and in-house and Field CRAs.
*Assist in development of monitoring plan after reviewing of IEC approved protocol; ICF; CRF.