Clinical Research Associate

4 weeks ago

Shanghai, Shanghai, China Fortrea Full time

Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Fortrea. As a Clinical Research Associate, you will be responsible for monitoring study sites, ensuring compliance with regulatory requirements, and maintaining accurate records.

Key Responsibilities

  1. Monitor study sites to ensure compliance with protocol guidelines and regulatory requirements.
  2. Conduct site initiation and close-out visits to ensure study sites are properly set up and study data is accurate.
  3. Review and verify data submitted on Case Report Forms (CRFs) or other data collection tools.
  4. Identify and report any discrepancies or issues with study data.
  5. Collaborate with vendors and other stakeholders to ensure study sites are properly equipped and staffed.
  6. Develop and maintain relationships with study site staff to ensure successful study execution.
  7. Participate in quality control visits to ensure study sites are meeting quality standards.
  8. Prepare and submit reports to management and other stakeholders as required.

Requirements

  • At least 1 year of clinical monitoring experience or equivalent combination of education and experience.
  • Ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Ability to work in a matrix environment and prioritize multiple tasks.
  • Fluent in English, both written and verbal.

Education/Qualifications/Certifications and Licenses

  • University or college degree or certification in a related allied health profession.
  • Thorough knowledge of ICH Guidelines and local regulatory requirements.
  • Basic understanding of the clinical trial process.
  • Valid driver's license.

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