Posted to MedZilla on 3/19/2018

EPM Scientific

US-CA, Contract Senior Clinical Research Associate 452431253729-MZ


Contract Senior Clinical Research Associate

Role: Senior Clinical Research Associate

Location: Irvine, CA

Therapeutic Area: Neurovascular – Medical Device

Duration: 12 Month Contract

  • Provides study management as the Project Leader
  • Assures successful conduct of assigned clinical studies consistent with R&D and Marketing plans and applicable regulations and policies. 
  • Interfaces with representatives from key functional groups including Clinical Affairs, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
  • Works with Director of Clinical Affairs to ensure study objectives, strategy, scope and schedule meet business needs.
  • Provides clinical interface with regulatory agencies, including pre-IDE meetings with the FDA

  • Minimum 4-7 years experience directly supporting clinical research or similar experience in a     medical/scientific area. 
  • Experience with direct reports and mentoring others
  • High attention to detail and accuracy.
  • Able to identify problems, develop solutions and implement to address study issues
  • Expertise with GCPs and regulatory compliance guidelines for clinical trials.

Contract Senior Clinical Research Associate

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