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Clinical Research Associate

Job Summary

  • 北京
  • Permanent
  • Ref ID: BBBH723441
  • Mar 05, 2019
  • RMB21,000 - RMB40,000 per month

Responsibilities

  • Clinical Trial Monitoring: Conduct Source data verification (SDV), Quality check of the documents during monitoring, cross-verifying the data recorded, reviewing informed consent form and patient eligibility. In case of any discrepancies, escalate for resolution. Conduct site-initiation and site-close out visits.
  • Identification of New Investigators: Identifying new investigators for the trial from different databases and establish contact. Conduct proper feasibility at the site to ensure patients are properly recruited and studies are conducted as per GCP (Good Clinical Practices) and schedule Y.
  • Budget Negotiations: Negotiating the budget for conducting trials with the sites as per defined range
  • Post - Marketing Surveillance of approved Products: Preparation of protocol and Case Report Form (CRF) for the marketed product to gather safety information as per regulatory requirement. Undertake CRF validation and submit data to data management team.

Requirements:

  • Understanding of ICH GCP, schedule Y and other regulatory guidelines; willing to travel for frequent site visits
  • MPharm - Pharmacology
  • 2 - 4 years post qualification experience
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