Clinical Research Associate I

2 weeks ago


Beijing, Beijing, China Parexel Full time

Job Summary: We are seeking a skilled Clinical Research Associate I (FSP) to join our team at Parexel.

About the Role:

  • Conduct Source Data Verification and Ensure Clinical Trials Data are Submitted in a Timely Fashion: The successful candidate will be responsible for conducting source data verification (SDV) and ensuring that clinical trials data are submitted to data management in a timely fashion.
  • Identify and Manage Site-Specific Issues: The candidate will identify issues that may impact the conduct of the study and ensure appropriate closure of all issues.
  • Proactively Manage a Greater Investigator Site Workload: The Clinical Research Associate I (FSP) will proactively manage a greater investigator site workload commensurate with experience, ensuring that studies are run efficiently and key study objectives are met.
  • Ensure Compliance with Regulations and SOPs: The successful candidate will ensure that studies are run in line with ICH/GCP, local laws, and Client Standard Operating Procedures (SOPs) and procedures.
  • Maintain Patient Safety and Report Safety Issues: The candidate will ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
  • Communicate Effectively with Site Staff: The Clinical Research Associate I (FSP) will inform the Principal Investigator (PI) and site staff of all issues and agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
  • Manage All Aspects of Site Management: The successful candidate will be responsible for all aspects of site management from collaboration on site selection to study closeout.
  • Train Site Staff on Protocol and Client Processes: The candidate will train site staff on the protocol, protocol amendments, and Client processes.
  • Understand Product, Protocol, and Therapy Area: The Clinical Research Associate I (FSP) will understand the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.


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