REGIONAL MONITOR (12-month, Potential for extension)
SUMMARY:
Clinical Research Associate needed for clinical trial regional monitoring and site management responsibilities for cardiology device research.
DUTIES & RESPONSIBILITIES:
• Site management, study start-up, communications and scheduling and conducting monitoring visits at clinical study sites.
• Team meetings and communications
• Study document review and discrepancy resolution and prevention support
• Preparing and editing visit reports within the allotted timeframe
• Other duties, as required.
QUALIFICATIONS & REQUIREMENTS:
• 5+ years of experience as a Regional Monitor CRA, including a minimum of two years of cardiovascular device trials (cardiology-specific devices preferred)
• Familiarity with ICH, GCP and FDA guidelines and requirements
• Good written, verbal and interpersonal communication skills & solid computer skills, including MS Office, EDC, eTMF and Excel trackers (must be able to ramp up quickly on custom trackers)
• Clinical Research Certification and experience with and understanding of cath reports and cath logs and are big pluses
LOCATION:
Work will be performed remotely from home and at study sites in the Western United States