The Senior CRA is responsible for working with research sites and the clinical research team to facilitate the successful and timely conduct of clinical investigation(s), building relationships, and effectively communicating ideas and results. The Senior CRA participates in all phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, Data Analysis, and Study Closure. The Senior CRA contributes to ongoing studies by designing case report forms, monitoring plans, and study and training documents; participates in data management and prepares clinical reports; performs remote, centralized and on-site monitoring; maintains in-house study files; provides day-to-day study management and site support; and interfaces with site coordinators, investigators, field clinical staff, and other company representatives. The Senior CRA ensures study and site compliance with applicable federal regulations and BIOTRONIK policies and procedures. Provides mentorship to Clinical Project Associate, CRA I and CRA II staff members in performing day to day responsibilities. The Senior CRA independently leads study or department projects.
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