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Clinical Research Associate II

1 month ago

Guangzhou, Guangdong, China SGA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Guangzhou Branch Full time
Job Summary

We are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team at SGA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Guangzhou Branch. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Monitor study sites to ensure compliance with protocol guidelines and regulatory requirements
  • Maintain accurate and detailed study files, including source documents and case report forms
  • Conduct pre-study and initiation visits to ensure site readiness and compliance
  • Verify informed consent procedures and protocol requirements are adhered to
  • Monitor data for missing or implausible data and ensure integrity of submitted data
  • Manage travel expenses and ensure audit readiness at the site level
  • Prepare accurate and timely trip reports
  • Perform other duties as assigned by management
Requirements
  • At least 1 year of clinical monitoring experience or equivalent combination of education and experience
  • Ability to work independently and with minimal supervision
  • Good planning, organization, and problem-solving skills
  • Excellent communication and interpersonal skills
  • Computer competency and fluency in English
  • Valid driver's license
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

Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.