Regional Monitor (Clinical Research Associate)
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 Apply To this Job