Clinical Research Associate II

2 months ago


Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time
Job Summary

BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd is seeking a highly motivated and experienced Clinical Research Associate II to join our team. 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 the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools.

Key Responsibilities
  • Monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
  • Ensure the study staff who will conduct the protocol have received the proper material and instructions to safely enter patients into the study.
  • Verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
  • Monitor data for missing or implausible data and ensure the integrity of the data submitted on CRFs or other data collection tools.
  • Perform other duties as assigned by management.
Requirements
  • At least 1 year of clinical monitoring experience or an equivalent combination of education and experience.
  • Ability to work with minimal supervision and have good planning, organization, and problem-solving skills.
  • Good communication and interpersonal skills, as well as good analytical and negotiation skills.
  • Computer competency and fluency in local office language and in English, both written and verbal.
  • Valid Driver's License.
Preferred Qualifications
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
About Us

BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd is a leading global contract research organization (CRO) 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, we are transforming drug and device development for partners and patients across the globe.



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