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Remote Clinical Research Associate

1 month ago

Maple Grove, United States The Fountain Group LLC Full time

my name is Daniel, and I am a Senior Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Research Associate for a prominent Medical Device client of ours. This position can be in any of these regions or (Remote / Maple Grove, MN / Sylmar, CA / Santa Clara, CA / Plano, TX). Details for the position are as follows:
 
Job Description:

  • Pay: 48.00-62.00/hr.
  • 6 month assignment to with strong chance of extension.
  • 2+ years at sponsor level for IVD / cardiovascular / pacemaker or other cardiovascular related devices is preferred.
  • Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
  • Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
  • Onsite and/or remote monitoring of data and overseeing corrective actions.
  • Drive schedule deliverables to meet the overall study timelines.
  • Develop and drive centralized processes to optimize instrument device data, reconciliation of instrument data to sample list, identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures.

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