Clinical Study Administrator

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. Provides solutions to a variety of issues relating to the conduct of a study of moderate scope and complexity. Typical Accountabilities: Assists in coordination and administration of clinical studies from the start-up to execution and close out. Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Serves as local administrative main contac...