Senior Clinical Research Associate I

3 weeks ago


Beijing, Beijing, China Parexel Full time
Job Summary

Parexel is seeking a highly skilled Senior Clinical Research Associate to join our team. As a key member of our team, you will be responsible for driving study performance at sites, performing site monitoring and other onsite visit activities, and providing monitoring visit reports within required timelines.

Key Responsibilities
  • Study Performance: Drive study performance at sites, perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.
  • Site Selection and Training: Contribute to the selection of potential sites and investigators, train, support and advise Investigators and site staff in study related matters.
  • Documentation and Supply Management: 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.
  • Data Verification and Reporting: Perform source data verification according to SDV plan, ensure data query resolution, work with data management to ensure quality of the study data, and ensure accurate and timely reporting of Serious Adverse Events.
  • Communication and Collaboration: Share relevant information on patient recruitment and study site progress within local Study Team, update VCV and other systems with data from centres as per required timelines, and prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.
  • Adherence to Company Policies: Adhere to client's Code of Conduct and company policies and procedures, and complete additional tasks assigned by manager, including study level tasks associated with Country Study Manager (CSM), acting as a mentor for junior team member, and co-monitoring less experienced CRA within study team.
  • Process Improvement and Knowledge Sharing: Contribute to process improvements, knowledge transfer and best practice sharing, and maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.
Requirements
  • Complete timesheets accurately as required.
  • Submit expense reports as required.
  • Update CV as required.


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