Clinical Research Assistant Resume - Free Download
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SAMPLE CRA CURRICULUM VITAE
John Smith, BA
422 ABC Drive
Alexandria, VA 22314
University of ABC
Bachelor of Arts – Biology
Clinical Research Associate
JKL Corporation 12/18/2005 to present
• Monitor the conduct of clinical trials, especially enrollment and quality of data.
• Verify subject safety and site adherence to FDA Regulations and ICH/GCP
• Ensure Adverse Events are reported appropriately, accurately and in a timely
manner and that follow-up activities are conducted as necessary.
• Review CRF, Informed Consent Documents and query language/narratives.
• Acquire specific clinical and therapeutic knowledge related to studies monitored.
• Conduct Qualification, Initiation, Interim and Closeout monitoring visits.
• Ensure complete and thorough study drug reconciliation.
• Manage trip reports, letters, query resolutions and expenses.
• Manage site master file contents and work with sites to ensure
communication requirements between site and IRB are adhered to.
• Provide support and timely follow-up for all audit and quality assurance activities.
Clinical Research Associate II 8/31/2004-12/17/05
• Monitored Phase III Trials.
• Verified subject safety and site adherence to FDA and ICH regulations/
• Conducted Pre-study, Initiation, Interim and Closeout visits.
• Managed trip reports, letters, queries and expenses.
• Ensured complete and thorough study drug reconciliation.
• Instructed sites in the use and maintenance of an IVRS and a CLIA waived