Description
Objectives:- To coordinate and execute clinical research activities for multisite clinical studies
- To ensure investigator and site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
- To ensure timely implementation of clinical research plans for assigned products
Responsibilities:
- Travels to field sites to monitor studies
- Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites
- Monitors the sites and provides technical assistance
- Assists with the coordination of training and certification of study site personnel
- Assumes accountability for the collection and maintenance of regulatory documentation
- Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline
- 4-6 years relevant clinical research experience
- Drug Development clinical trial experience
- Strong science background; lab experience preferred
- 2-4 of field monitoring experience
- Able to travel 15-35 %
To find out more about Real please visit www.realstaffing.com