Lori Garner Email & Phone Number

Cambridge, Cambridgeshire, Gb

Cambridge, Cambridgeshire, Gb

Raleigh, North Carolina, Us

• 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 atinvestigative 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 trialmanagement 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 clinicalissues• 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-GCPguidelines• 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 andfacilitate trial timelines• May be assigned clinical tasks where advanced negotiating skills are required

• Completed projects on an ad hoc basis anywhere from two days to one month in length on several contracts on various multi site clinical trials• Participated in study start up process• Site selection: Collected study start up documentations, review FDA disbarred, restricted, and NIDPOE lists• Investigated any queries between site and company• Revised and maintained regulatory documentations for the site and sponsor trial master file (TMF)• Reviewed clinical data to ensure accuracy, completion and integrity of data• Created data storage packets, which greatly improved the handling of regulatory and study related documents by 30%.• Conducted site monitoring at Center for Neuromodulation The Icahn School of Medicine at Mount Sinai, Dr. Brian Kopell MD, Director • An ongoing project studying the effects of cortical stimulation for the treatment of Depression. • Conducted IMV, and study close out visit• Tracking EDC and query follow-up to resolution