Description
Objectives:- 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
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
- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- With guidance, ensures accurate and complete study management/data collection and transfer into the data management system
- Conducts reference material testing in-house
- Assists, prepares and manages study timelines
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline
- Clinical trial experience with medical device or diagnostics
- 2+ years of field monitoring experience
- Strong science research/lab background
- Ability to travel up to 25%
To find out more about Real please visit www.realstaffing.com