Clinical Research Associate Specialist

4 weeks ago


Beijing, Beijing, China Parexel Full time

About the Role

We are seeking an experienced Clinical Research Associate to join our team. As a Senior Clinical Research Associate I, you will be responsible for driving study performance at sites, performing site monitoring and onsite visit activities according to the monitoring plan and in compliance with procedural documents.

Key Responsibilities

  • Drive study performance at sites, ensuring timely completion of monitoring visits and submission of required reports.
  • Select potential sites and investigators, providing training and support as needed.
  • Obtain and maintain essential documentation in compliance with ICH-GCP, procedural documents, and local regulations.
  • Manage study supplies, drug supplies, and drug accountability at study sites.
  • Perform source data verification according to the SDV plan, ensuring accurate and timely reporting of Serious Adverse Events.
  • Share relevant information on patient recruitment and study site progress within the local Study Team.
  • Prepare for audits and regulatory inspections in liaison with the local Study Team Lead and QA.

Additional Tasks

  • Contribute to process improvements, knowledge transfer, and best practice sharing.
  • Act as a mentor for junior team members and co-monitor less-experienced CRAs within the study team.

Requirements

  • Comply with required training curriculum.
  • Complete timesheets accurately as required.
  • Submit expense reports as required.
  • Update CV as required.
  • Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements.

Estimated Salary Range: $60,000 - $80,000 per year, depending on experience.



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