Description
Goals:- Ensure timely implementation of clinical research plans for assigned products
- Ensure investigator and site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
- Coordinate and execute clinical research activities for multisite clinical studies
Roles:
- Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects
- Monitors the sites and provides technical assistance
- Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites
- With guidance, ensures accurate and complete study management/data collection and transfer into the data management system
- Supports the organization of investigator meetings
- Assists, prepares and manages study timelines
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline
- 4-6 years relevant clinical research experience
- Clinical trial experience with medical device or diagnostics
- 2+ years of field monitoring experience
- Travel up to 25%, as required.
To find out more about Real please visit www.realstaffing.com