Description
Primary Duties:- Participates in the design, planning, implementation and overall direction of clinical research projects
- Some travel required to field sites to monitor studies
- Reviews study protocols, reports and manuscripts; Contributes technical and clinical operations expertise for these documents
- Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites
- Assumes accountability for the collection and maintenance of regulatory documentation
- Assists with the coordination of training and certification of study site personnel
- With guidance, ensures accurate and complete study management/data collection and transfer into the data management system
- Manages material logistics for the studies
- Supports the organization of investigator meetings, as necessary
- Assists, prepares and manages study timelines
Skills & Education:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline
- Excellent written and verbal communication skills in English
- Experience conducting all types of monitoring visits from site qualification, site initation, routine to close out
- Familiarity with Electronic Data Capture (EDC)
- Firm understanding of GCP
- Laboratory / PCR technology experience preferred
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2-6 years relevant clinical research experience; 4-6 years preferred (medical device and/or IVD industry experience highly desirable)
To find out more about Real please visit www.realstaffing.com