| Job Summary |
The Clinical Operations Manager will lead, direct, and coordinate the operational efforts in the development and implementation of research-driven, investigator-initiated clinical trials, supported and conducted by the Immune Tolerance Network (ITN) at UCSF and sponsored by the National Institutes of Health (NIH); ensure the efficient conduct of all activities from protocol development through completion of the trial; assemble and lead the multidisciplinary study management team charged with establishing the project goals for protocol development and trial implementation by preparing and/or reviewing all trial-related documents and budgets, planning and documenting trial activities, providing CRO/vendor management, and clinical trial site management.
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| Qualifications |
BS/BA in a health-related science or RN, 5 years of experience in clinical research, clinical coordinator, clinical nurse role or an equivalent combination of education and experience; in-depth knowledge of FDA, ICH, and GCP guidelines and experience implementing, monitoring, and/or managing clinical trials for academic clinical research or pharmaceutical/biotechnology company; ability to work collaboratively, effectively, and productively with a diverse collection of professionals: medical staff, regulatory personnel, clinical investigators, biostatisticians, and government administrators; ability to demonstrate strong leadership capabilities, negotiation skills, excellent communication skills (both verbal and written), proven project management and organizational skills, and the ability to motivate and direct others; excellent knowledge of MS Office Suite and working knowledge of MS Project, willingness to travel occasionally for essential investigator meetings and periodic meetings with other ITN groups or NIH representatives.
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