Clinical Research Associate

hace 19 horas

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

About the Role:

We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will play a vital role in ensuring the successful delivery of clinical trials.

Job Summary:

The Clinical Research Associate will be responsible for coordinating and conducting site management activities, including monitoring visits, data review, and compliance assessment. You will work closely with investigators, study sites, and other stakeholders to ensure that trials are conducted in accordance with ICH GCP, FDA guidelines, and local regulations.

Key Responsibilities:

  • Conduct site initiation visits, monitoring visits, and close-out visits to assess protocol and regulatory compliance
  • Review and verify source documents, including patient records and clinic notes
  • Assess investigational product through physical inventory and records review
  • Escalate observed deficiencies and issues to clinical management expeditiously, proposing solutions and following up on issues until resolution
  • Maintain regular contact between monitoring visits with investigative sites to ensure compliance with the protocol
  • Provide trial status tracking and progress update reports to the Clinical Team Manager as needed
  • Perform QC checks of reports generated from CTMS systems where required
  • Participate in investigator meetings and identify potential investigators to ensure the acceptability of qualified sites
  • Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory requirements

Requirements:

To be successful in this role, you will need:

  • A bachelor's degree in a life sciences-related field or a registered nursing certification
  • 4+ years of experience in clinical research monitoring
  • Valid driver's license where applicable
  • Strong communication and interpersonal skills, with the ability to build effective relationships with investigators and other stakeholders
  • Excellent problem-solving and analytical skills, with the ability to escalate issues to clinical management as needed
  • Proficiency in CTMS systems and other software applications relevant to the role

What We Offer:

In return for your expertise and dedication, we offer a competitive salary and benefits package, including:

  • An estimated salary range of $65,000 - $85,000 per year
  • A comprehensive health insurance plan
  • A 401(k) retirement savings plan with company match
  • A generous paid time off policy
  • Professional development opportunities to help you grow your career

Location:

This role is based in Barranquilla or Cali, Colombia. Regular travel to investigative sites is required, with an estimated 60-80% of time spent on the road.

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