I am a Seasoned Professional possessing diverse business skills that encompass people, project/program, a strong healthcare background and I am ready to contribute to Mayo Clinic’s organizational needs. Experiences span across Clinical Research, Health Insurance, Billing and Auditing of patient Accounts ,Curriculum development and I was the Director of Education at Bryan College,. I am committed to excellence and to Mayo Clinic’s values by ensuring all projects support the strategic mission and objectives while delivering within Scope, Time, Cost and Compliance
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Provide exceptional Data Coordination on current clinical trials assigned to me, including collaboration with Clinical Research Coordinators and Principal Investigators to make sure all data is accurately captured for the study.
Successfully coordinated clinical trials assigned.
140 hours of education indepth
learning on:
• ICH GCP E6 R(2)
• FDA Regulations 21CFR 11, 50, 54,56 and the Common
Rule 45CFR46
• Data Management
• Informed Consent Process
• Clinical Trial Operations from feasibility through close-out.
• GDP following ALCOA-C principles
• Identification and reporting of AEs and SAEs
• Quality Assurance, Monitoring and Query Resolution
• Comprehension and Execution of Clinical Trial Protocols
• Maintaining regulatory binder, housing essential
documents including but not limited to 1572, DOA,
Training Logs and other Investigator Site File (ISF)
documents
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