Clinical Research Associate

1 week ago


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

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd. As a Clinical Research Associate, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.

Key Responsibilities
  1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
  2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  4. Monitor data for missing or implausible data.
  5. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  6. Ensure audit readiness at the site level.
  7. Travel, including air travel, may be required and is an essential function of the job.
  8. Prepare accurate and timely trip reports.
  9. Manage small projects under direction of a Project Manager/Director as assigned.
Requirements
  • Two (2) years of Clinical Monitoring experience.
  • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Advanced site monitoring skills.
  • Advanced study site management skills.
  • Advanced registry administration skills.
  • Ability to work with minimal supervision.
  • Good planning and organization skills.
  • Good computer skills with good working knowledge of a range of computer packages.
  • Advanced verbal and written communication skills.
  • Ability to train and supervise junior staff.
  • Ability to resolve project-related problems and prioritizes workload for self and team.
  • Ability to work within a project team.
  • Works efficiently and effectively in a matrix environment.
About Us

Fortrea 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 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.



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