Description
Essential Job Functions:- Plans, implements and executes FDA registration trials to support clinical claims
- Assists team in budget and contract negotiations with study sites, central laboratories and CROs
- Study start up, monitoring and study close out activities being performed within the team
- Plans and prepares execution of studies through all phases of the study process
- Provides technical support to study designs and clinical development plans
- Works with Data Management and Biometrics staff on the design of documents and processes for the collection of study data from participating sites
- Ensures compliance with GCP, regulations, SOPs and protocols
- Supports the preparation of reports and summary documents for product registration
Requirements:
- 4-6 years of CRA experience
- Oncology clinical trial experience preferred
- IVD experience preferred
- BS in scientific discipline
- Global/international clinical trial experience
- Laboratory or science research background preferred
- CRO/vendor management; budget and contract development
- Up to 35% travel during occasional peak periods
To find out more about Real please visit www.realstaffing.com