Clinical research professional with Medical Doctorate and 12 years of pharmaceutical and biotechnology industry experience in various therapeutic areas is seeking a full-time position in Clinical Operations/ Medical Affairs.
• Develop and review clinical documents (Protocols, IB, and ICFs) for submission to the regulatory authorities.
• Develop and review other clinical study related documents, such as monitoring plans, monitoring reports, investigator questionnaires, CRFs, test article accountability records, study manuals, tracking tools, and training materials.
• Develop and review clinical SOPs and develop other procedural documents, such as guidance documents.
Review protocol and other clinical study related documents for clinical/safety input; Develop safety narrative reports; Develop protocol/safety training materials for Investigator Meeting/Site Initiation Visit and clinical study team; Develop clinical sections of INDs and Clinical Study Reports (CSRs).
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