Added
23 days ago
Type
Full time
Salary
Salary not provided

Related skills

gcp informed consent site monitoring regulatory submissions ctms

๐Ÿ“‹ Description

  • Oversees all aspects of study site management to protect patient safety and data quality.
  • Serves as primary site contact and ensures adherence to ICH-GCP and SOPs.
  • Manages trial tools, status reports, and monitoring documentation.
  • Conducts site visits (pre-study, initiation, routine, close-out) with timely reports.
  • Coordinates site startup activities: feasibility, IRB submissions, and consent.
  • Travels 60-70% to support global studies and IP handling.

๐ŸŽฏ Requirements

  • Bachelor's degree or international equivalent in science or healthcare.
  • Minimum 2 years of on-site CRAII monitoring; oncology/Phase I preferred.
  • Strong knowledge of ICH-GCP, GPP, SOPs, and regulatory guidance.
  • Proficiency with Microsoft Office; fluent in English (verbal and written).
  • Ability to travel 60-70% and work independently in a remote environment.
  • Excellent organizational, communication, and data quality focus.

๐ŸŽ Benefits

  • We are an Equal Opportunity Employer.
  • Growing organization serving cancer therapies.
  • Remote-friendly environment with cross-functional teams.
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