Brooke AuBuchon

Following guidelines consistent with Good Clinical Practices and internal Standard Operating Procedures. Review patient image data for analysis and expert review as required by the FDA Assist in the design of the imaging and efficacy portions of the clinical protocols as well as the Expert Review protocol Manage sites/imaging center, providing critical analysis as to the capability of a center to perform required imaging related procedures for a clinical trial. Provide critique analysis on quality of data obtained. Advise imaging centers on ensuing issues that arise during required procedures, while making evaluations /recommendations on discontinuance of the centers participation. Provide analysis as to the practical design of imaging procedures and design of quantifiable efficacy endpoints. Writer and implement the Expert Review procedures, design the randomization procedure to best display image data for obtaining the primary efficacy endpoint data. Work with Data Management to design case report forms for this process. Attend Investigator meetings and present protocol related image processing. Present the process and procedures for image data acquisition and archival to investigator and study coordinators. Serve as an expert panelist to answer questions on the efficacy design and imaging procedures. Oversee simultaneous project events and maintaining progress to successful completion and customer satisfaction. Effectively manage the efforts required to ensure that all key deliverables are identified and produced in a timely manner at study start-up through close-out. Communicating timely, appropriate project information to project teams, sites, and company/sponsor representative(s) Other duties as deemed necessary to ensure high quality service.