Crystal Kohn
Senior Clinical Trial Lead @Allucent
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WORK HISTORY
Senior Clinical Trial Lead @Allucent
Experience in Early Phase, Oncology, Cell and Gene (CAR-T) studies.Provides leadership and management to the CRA and clinical functional groups, in their day-today activities including interaction with investigative sites and team members on global, multi-country or regional basis.Responsible for managing the planning, implementation, and tracking of the clinical monitoring processManages the study start up in collaboration with PM, Regulatory Lead and Global Site Activation Manager Customizing site visit report checklists/templates and their annotated versions according to study specific requirements Selection of investigators and sites; SEV report review and approvalMonitoring Visit Report review, management, resolution, and escalationManages successful trial close-out, identifies critical activities to make timely and efficient close-outResponsible for timelines, budget and quality of clinical monitoring team deliverables, identification of risks and issues and escalation to PM, Line manager, CRMs/COMsMonitor and manage trial materials supplies. Ensures Investigational Product and other study supplies are shipped to sitesReview data listings and query reports to identify trends and ensures proactive retraining is conducted with CRAs and site staff.Monitors clinical operations staffing, workload, and resources and reports study deliverable and resource needAssists with PM in discussions with clients on study documentation issues or technical related documentation concerns and supports PM in management of study vendorsReviews study systems (CTMS, CRF, IRS, Central lab portal, etc) updates on regular basis, ensures systems reports are up to date and reports generated are current and correctAssists and supports study specific training and preparations of study presentations to potential clients and at Investigators meeting Participates in preparation, attendance and presentation of bid defense or any other study related meeting
EDUCATION
Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine
Master of Public Health (M.P.H.), Epidemiology
University of Houston
Bachelor of Science (B.S.), Biology, General
ABOUT CRYSTAL KOHN
Experienced Clinical Trial Manager in Early phase studies, Oncology, and CAR-T. Has extensive project management and operational knowledge in planning/executing/reporting clinical trials within timelines and budgets. Skills include knowledge of GCP guidelines, regulatory clinical development processes, and patient safety. Exceptional cross-team collaboration and leadership skills as well as the ability to be self-sufficient.
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