Within the Clinical Trials Unit (CTU) in the Center for Cellular Therapies (CCI), the Clinical Research Coordinator C (CRC-C) will work with various principle investigators to oversee several aspects of the research being performed for their Phase I-Phase II clinical research studies, patient enrollment and follow-up, study monitoring activities, data collection, project maintenance and project close-out activities. The CRC-C will be the principal liaison to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues to both the investigators and sponsor team members.
Responsibilities Include: * Manage and coordinate clinical trials and provides regular project updates to sponsors and upper management. * Liaison between the research and clinical entities working under the auspices of the CTU and CCI * Ensures compliance with project management timelines, milestones, and communicates limitations to investigators and sponsors. * Monitor project status and timelines * Assist in the development of unit Forms/Templates to be congruent with unit SOPs * Coordination of site initiation visit/unit training with sponsor teams * Execute/write protocol exceptions/deviations for submission * Review/report the status of case report form completion and data query resolution. * Participate in SOP development.
Internal Number: 44797
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