• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits • Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Manage and track the preparation and return of investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues • Review data queries and listings, and work with study centers to resolve data discrepancies • Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues • Maintain complete and accurate study files and review files to ensure all appropriate documentation is present • Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials • Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues