Description
Title: Sr. Clinical Research AssociateType: Contract (contract to hire)
Duties:
- Assist with overall clinical trial operations
- Monitor and evaluate flow of clinical data to ensure accuracy
- Write protocols, informed consent forms, study manuals, and final reports
- CRO/vendor management
- Travel to investigational sites to conduct pre-study, initiation, interim, and closeout site visits
Requirements:
- BS or equivalent
- 6+ years of clinical research experience in the medical device/diagnostics industry
- Strong knowledge of FDA regulatory requirements
- Abilitity to travel up to 25%
- Experience with FDA submissions and inspections