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Senior Specialist, Clinical Research Monitoring (In-House CRA with Field Monitoring, Irvine, CA) – Heart Valve Therapy

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time
Contact Name: Mimi Omelas
Phone:
Fax:
Email: apply directly online (see below)
Salary:

Job Description

Edwards Lifesciences surgical Heart Valve Therapy (HVT) group has an exciting opportunity for a Sr. Specialist, Clinical Research Monitoring.  This role is In-House CRA with Field Monitoring – based out of Irvine, CA. 

The Sr. Specialist, Clinical Research Monitoring Operations ensures trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. 

Key Responsibilities:

  • Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
  • Up to 50% travel, Continental United States and Canada
  • In-House CRA with monitoring responsibilities
  • Position based out of and located in Irvine, California


Job Requirements 

Required: 

  • Bachelor's Degree with 5 years (or Associate’s Degree with 7 years) of hands-on clinical research experience; including field monitoring experience.
  • Medical Device trial experience
  • Cardiovascular device trials strongly preferred

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=013539&lang=en