Added
2 hours ago
Type
Full time
Salary
Salary not provided

Related skills

monitoring edc ip tmf ich-gcp
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๐Ÿ“‹ Description

  • Supports study sites and clinical project teams in clinical research studies.
  • Ensures adherence to protocols, SOPs, ICH-GCP, GPP, and country regulations.
  • Conducts site visits (pre-study, initiation, routine, close-out) and remote monitoring.
  • Manages trial tools, status reports, and site/start-up activities when needed.
  • Oversees patient safety, data quality, IP handling, and SAE reporting.

๐ŸŽฏ Requirements

  • Bachelor's degree or international equivalent; 3+ years on-site monitoring; oncology/Phase I
  • Strong knowledge of ICH-GCP, regulatory guidance, and SOPs.
  • Excellent organizational skills; fluent English; capable of remote work.
  • Travel 60-70% as required; solid data management and communication skills.
  • Experience with IP inventory, ISF/TMF reconciliation, and EDC data review.
  • Preferred: clinical research experience and familiarity with budget/contract processes.

๐ŸŽ Benefits

  • Opportunity to contribute to cancer therapies with a growing CRO.
  • Collaborative environment and opportunities for professional development.
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