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Shay K. | Elance
 
176985602337900
Last Sign-in: Jan 17, 2015

Shay K.

Clinical Research / Medical Writing
   United States
  |   Pasadena, CA
  |  12:36 am Local Time

Overview

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.

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Skills (2)

Tested

Service Description

Clinical Operations:
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.

Medical Affairs:
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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skhan_md
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November 2014
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Shay K. | Elance

Shay K.