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Clinical Research Associate

hace 2 meses

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo
{"title": "Clinical Research Associate", "content": "Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for coordinating all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, and local regulations.

Key Responsibilities
  • Monitor investigator sites to ensure accuracy and validity of CRF entries in relation to patient records/clinic notes.
  • Assess investigational product through physical inventory and records review, documenting observations in reports and letters.
  • Escalate observed deficiencies and issues to clinical management, proposing solutions and following through to resolution.
  • Maintain regular contact between monitoring visits with investigative sites to ensure protocol compliance and data recording.
  • Conduct monitoring tasks in accordance with the approved monitoring plan.
  • Provide trial status tracking and progress update reports to the Clinical Team Manager.
  • Participate in investigator meetings and identify potential investigators to ensure acceptability of qualified sites.
  • Contribute to the project team by assisting in preparation of project publications and sharing ideas with team members.
Requirements
  • Bachelor's degree in a life sciences related field or a Registered Nursing certification.
  • Previous experience as a clinical research monitor (comparable to 4+ years).
  • Valid driver's license where applicable.
Location

Based in Barranquilla or Cali, with availability to travel/visit sites.

", "lang_code": "en-US"}