Paige Matisak

Clinical Research Associate Ii @ICON plc

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely• Provides regular site status information to team members, trial management, and updates trial management tools• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed• Performs essential document site file reconciliation• Performs source document verification and query resolution• Assesses IP accountability, dispensation, and compliance at the investigative sites• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines• Communicates with investigative sites• Updates applicable tracking systems• Ensures all required training is completed and documented• Serves as observation visit leader• Facilitates audit s and audit resolution• Mentors junior level CRAs and serves as a resource for new employees• Serves as observation and performance visit leader• May be assigned additional Clinical Operations tasks• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines• May be assigned clinical tasks where advanced negotiating skills are required