Description
Job Duties:- Plans, implements and executes FDA registration trials to support clinical claims
- Supports the preparation of reports and summary documents for product registration
- 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
- Reviews study protocols, reports and manuscripts
- Ensures site compliance with regulations and study protocol
Requirements:
- 3+ years of Clinical Research Associate experience
- IVD experience preferred; Oncology clinical trial experience highly preferred
- Laboratory/Med Tech background preferred
- BS in Biology,Chemistry, Molecular Bio or related discipline
- Field monitoring experience; vendor management experience
- Up to 35% travel during peak periods