Description
Essential Duties and Responsibilities:- Responsible for assisting senior staff in planning study conduct, Contract Research Organization (CRO) selection and management, selection and training of investigator sites, evaluation, selection and training of new study investigators;
- Responsible for overseeing CRAs monitoring investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRF's from study sites, processing CRF's including data cleanup and classification of data, maintaining study files, and completion of study summary;
- Reponsible for managing all third party vendors involved with the clinical study;
- Responsible for assisting in the writing of basic study protocols (confirming clincial study procedures.
Education: Minimum: Four year College Degree; BS in a scientific discipline preferred
Experience: Four years functioning as a CRA with a Minimum 6 years of experience at a pharmaceutical/biotech company or CRO. CRA certitication (e.g., ACRP, SoCRA) preferred, understanding of drug development process, ICH/FDA Guidelines, and Good Clinical Practices.
Specific Skills: Independently coordinate and supervise all aspects of Clinical Trials including developing and writing monitoring guidelines, site selection, managing and providing support to CRAs, ensuring GCP/ICH compliance of day-to-day clinical trials activities and acting as the primary liaison for study site staff, CRO's, and other vendors. Must demonstrate deep and broad knowledge of clinical research complemented by reliable and effective project management capabilities. Travel Requirements (up to 20%)
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