Description
Responsibilities:- The CRA assists with the implementation and conduct of clinical studies, focusing on the areas of protocol development, study planning, site monitoring and/or monitoring management, enrollment, data quality and study reporting.
- Manages Trial Master File (TMF) and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor
- Prepares study documents for assigned studies, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual
Requirements:
- Understanding of the study phases and general knowledge of how they apply to drug development
- Bachelor's degree in a biological science is preferred
- Requires a minimum of 3-4 years' experience as a CRA, with orphan drug/disease and/or pediatric knowledge very helpful
- Previous experience in pharmaceutical industry required
To find out more about Real please visit www.realstaffing.com