Description
Responsibilities:- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- Travels to field sites to monitor studies
- 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
- Ensures site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
Objectives of the Position
- To ensure timely implementation of clinical research plans for assigned products
- To ensure investigator and site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
- To coordinate and execute clinical research activities for multisite clinical studies
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline
- 4-6 years relevant clinical research experience
- Able to accommodate 15-35% travel during occasional peak periods
To find out more about Real please visit www.realstaffing.com