Sr CRA

hace 1 mes


Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

Job Description:

As a Monitoring Specialist, you will be responsible for overseeing investigator sites using a risk-based monitoring approach. You will utilize root cause analysis, critical thinking, and problem-solving skills to identify and address site process failures. Your main goal is to ensure compliance, reduce risks, and maintain data accuracy through various monitoring activities.

  • Monitor investigator sites using RCA and problem-solving skills to identify and address process failures.
  • Ensure data accuracy through SDR, SDV, and CRF review.
  • Conduct physical inventory and records review of investigational products.
  • Document observations promptly following approved business writing standards.
  • Communicate deficiencies and issues to clinical management efficiently.
  • Maintain regular contact with investigative sites to verify protocol adherence and data recording.
  • Participate in investigator meetings and assist in identifying potential investigators.
  • Initiate clinical trial sites according to relevant procedures and regulations.
  • Ensure trial close out and retrieval of trial materials.
  • Review essential documents for completeness and compliance.
  • Contribute to project publications and tools and share ideas with team members.
  • Facilitate communication between sites, client company, and project team.
  • Respond to regulatory requirements, audits, and inspections.
  • Complete administrative tasks like expense reports and timesheets promptly.
  • Participate in process improvement initiatives as needed.


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