Kyle C. Email & Phone Number

Greater Denver Area

-Serve as main point of contact for all industry sponsored clinical trials for the Department of Neurology at the University of Colorado Anschutz Medical Campus. -Responsible for all IRB submissions and oversight for sponsored clinical trials - maintenance of investigator site files including management of current GCP trainings and relevant research staff documents (CVs, medical licenses, etc.). -Ensure regulatory compliance on site per and protocol guidelines.-Development and edits to site SOPs.-Prepare and participate in site qualification, initiation, routine, and close out visits with CRAs-Process protocol amendments to IRB (ICF, subject facing materials, etc.)-Negotiate industry budgets for clinical trials with CRO/sponsors. Review financial contract language prior to full execution and logistical analyses for all incoming industry sponsored trials.-Educate research staff on study protocols, train study staff on protocol & corresponding amendments.-Manage student research assistants - educate on importance of data integrity in clinical research, manage workloads, and mentor those interested in clinical research careers.-Served as main point of contact for site as a part of the NeuroNEXT Center of Excellence - completed progress reports, feasibilities, and community outreach.-Perform routine QA check on source documentation and provide training to research coordinators on proper GCP guidelines, SAE reporting, and good documentation practices.

Greater Denver Area

-Conducted trials per protocol on various neurological clinical trials (MS, headache/migraine, TBI, etc.). -Enrolled, consented, and monitored subjects in Phase III clinical trials.-Completed, maintained, and created source documents, underwent extensive protocol review for all studies participated in, etc. -Performed cognitive rating assessments for subjects in various trials.-Work closely with PIs to ensure proper PI oversight and review of patient safety.-Query management and EDC data entry.