• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals.
• Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...
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Florida, Pharmaceutical Research, Monitoring, Management, Team Building
Summary of Qualifications and Skills Graduate prepared nurse with a Clinical Specialist in Oncology with a minor in HIV Disease. Broad pharmaceutical experience, starting as a Research Coordinator in academia, an in-house Clinical Research Associate (CRA) in Biotech, Associate Director in Global Operations in Clinical Pharmacology with Aventis Pharmaceuticals, and as a home-based CRA Responsibly managed multiple projects an...
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Clinical Research, Research, Pharmaceutical Industry, Process Improvement, Project Leader, Project Management, Research and Development, Oncology, Medical/Surgical, HIV Disease, Long-term Care, Community-Based Care, Clinical Nurse Specialist, Remote Data Entry, Delaware, OH, Columbus, OH, Portland, OR, San Francisco, CA
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
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Chemistry, Research, Sar
Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms
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Accounting, Policies and Procedures, Project Management, Project Manager, Protocol, Documentation, Cardiology, Clinical Research, Orthopedics, Research
SUMMARY OF QUALIFICATIONS: Expertise working in a regulated environment following Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs) in both analytical and animal toxicology laboratories. Maintains and oversees sample management operations including the Rees environmental monitoring system, Watson sample acquisition information and tracking of GLP Bioanalytical & Immuno...
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Audit, Documentation, Monitoring, Process Improvements, Quality, Quality Assurance, Quality Control, Test, Transportation, Customer Service
