Added
1 day ago
Type
Full time
Salary
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Related skills

gcp edc informed consent regulatory submissions ip

๐Ÿ“‹ Description

  • Oversees site management to protect patient safety and data quality.
  • Guides audit readiness and supports audits and follow-up actions.
  • Maintains trial tools, trackers, and status reports.
  • Manages site start-up tasks: feasibility, recruitment, IRB/EC submissions, docs.
  • Performs IP inventory, labeling, and dispensation per protocol.
  • Conducts on-site and remote monitoring visits; prepares monitoring reports.

๐ŸŽฏ Requirements

  • 4-year college degree or equivalent in science/healthcare.
  • 2+ years CRA experience in a CRO or equivalent (site management).
  • Excellent communication and organizational skills; team player.
  • Ability to travel up to 60%, including international travel.
  • Experience with EDC, IP tracking, ISF/TMF, and regulatory documents.
  • Fluency in English; local language for non-English sites.

๐ŸŽ Benefits

  • Paid time off and volunteer time off.
  • Comprehensive medical benefits and 401k with company match.
  • Paid parental leave and disability coverage.
  • Training and professional development opportunities.
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