Karla Shields Email & Phone Number

Phoenix, Arizona, United States

Ensuring safety and compliance for clinical trailsPrescreening patients for clinical trial eligibilityCoordinating apheresis and cell infusion appointments Scheduling and organizing patient schedules, per protocol assessment schedulesAdvising medical team(s) on proper triage plans, per protocol guidelinesCoordinating patient appointments for clinical trailsResponsible for multiple clinical trials and enrolling new patientsUpdating legal documents so that we are in compliance with IRB and FDA regulationsPreparing for continuing reviews, study opening, and study closingProtocol compliance and safety Adding patients to PTrax for trail trackingConsenting patients for clinical studiesGathering data on patients and assessmentsPreparing for monitor and all-sites meetingsWorking with data coordinators to complete queriesSubmitting Series Adverse Event forms (SAE’s)Patient appointments – updating needed information for clinical trials, such as: AE’s, conmeds, surgical history, and medical historyCommunicating with study sponsors, both internal and external of the Mayo Clinic organization

Preparation and submission of the IRB application processScheduling research volunteer appointments Consented volunteersCollected biometric measurements Administered questionnaire to measure anxiety and depression in volunteerscollected, coded and analyzed dataFacilitated recruitment, enrollment, and retention of participants