Clinical Research Associate II
St. Jude Medical - Plymouth, MN

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The Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.

  • Follows department Standard Operating Procedures
  • Sets up sites: clinical research agreements, IRB Approvals, etc
  • Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations
  • Assists Regulatory in annual report and progress reports to the FDA
  • Organizes Investigator and Data Safety Monitoring Board meetings
  • Reviews data forms and DCF generation
  • Conducts field audits to assure protocol compliance and data integrity
  • Generates presentations when requested by investigators of AGA personnel
  • Generates follow-up reminder reports and sends to investigators or AGA personnel
  • Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries
  • Acquires professional, product and market expertise via independent reading, networking and training
  • Counsels and trains newly hired CRAs and monitors
  • Travels approximately 20%
  • Participates in professional activities outside of normal business hours
  • Performs other related duties as requested
  • BA/BS in business, science or nursing
  • 2 - 4 years experience in clinical research including monitoring
  • Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization
  • Excellent written and verbal communication skills
  • Ability to work independently and take direction from others
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St. Jude Medical - 2 years ago - save job - block
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