Description
My client is looking for a CRA with 2-6 years of industry experience within the Pharma, Biotech, or Medical Device industry. This position requires 2+ years of monitoring experience, preferrably within medical devices.Responsibilities include, but not limited to:
Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; Travels to field sites to monitor studies; Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents; Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites; Assumes responsibility for training and coordinating certification of study site personnel; Ensures accurate and complete study management/data collection and transfer to data management; Ensures site compliance with regulations and study protocol; Monitors the sites and provides technical assistance, as necessary; Assists, prepares and manages study timelines; Conducts reference material testing in-house; Organizes investigator meetings, as necessary
Education: Bachelors Degree or Masters Degree, Life Sciences preferred
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