Responsibilities
Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements.
Klinik araştırmacılar/tesis personeli için birincil irtibat noktası olarak işlev görme.
Tanımlamak, hak kazanmak, başlatmak, Klinik sahalarını izleyin ve kapatın.
Siteyle ilgili sorunlar ortaya çıktığında CRO ile birlikte izleme.
Assist in the selection and oversight of Contract Research organizations and other vendors.
Reviews adverse events and other data listings to identify issues with study conduct or compliance.
Assist with protocol and case report form development, drafts trail-related documents and operational procedures, collects regulatory documents, and maintains clinical files.
Gereksinimler
Bachelors degree, preferably in the Life Sciences, or a minimum of 3 years clinical research experience; içermek 2 years site monitoring.
Experience with Phase I and/or bioequivalence studies and an understanding of GCP and ICH guidelines.
Must be willing to travel a minimum of 40% domestically/internationally as required.
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