Clinical Research Associate
June 2012 — July 2013
Evaluated the quality and integrity of study site practices related to the proper conduct of protocols and adherence to
Escalated quality issues to Clinical Team Lead (CTL) and/or line manager as appropriate.
Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Performed site selection, and monitoring visits in accordance with contracted scope of work and good clinical practice.
Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reporting documentation and other required study related documents during the trial.