Carla Urban

My responsibilities include, but are not limited to applying expertise and independent judgment to independently verifying patient safety and patient rights, performing clinical on-site monitoring activities, collecting regulatory documentation, ensuring timely and high quality data, and performing qualification, initiation, monitoring, and termination of investigational sites in accordance with ICH GCP guidelines. THERAPEUTIC AREA EXPERTISE: Gastroenterology, Genitourinary, Rheumatology, Oncology

Project Assistant within the Project Planning and Support Department

Work placement within the On Site and In-house Monitoring Department • Participation in on-site visits (qualification visit, initiation visit, monitoring visit, close-out visit) • Conduction of Feasibility • Preparation and conduction of Remote Monitoring Calls • In-house site management • Preparation of Investigator Site Files • Maintenance of electronic and paper Central Files • Entering data into Clinical Trial Management Systems

• Supporting the Monitoring Department • Quality Management/Quality Control of Amendment Submission Documents • SOP review and translation • Trial Master File review • Study data entry