Job Description

Conduct on-site clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines, and Excel's/sponsor's SOPs. Perform on-site visits, including site qualification, initiation, monitoring and closeout visits. Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Maintaining regular contact with study sites to ensure protocol/GCP compliance. Communicate progress of study and relevant information to Project Manager and other project team members. Complete accurate study status reports in time. Deal with CRF queries in a timely manner. Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report. Ensure correct archiving of files on completion of a study.