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Clinical Research Associate Assistant
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CORE JOB TASK:
  • Conduct study/site feasibility, recommend and evaluate investigators/study sites.
  • Conduct study preparation, initiation, investigator/site training/meeting, monitoring, and closeout ensuring compliance with applicable protocols, regulations, GCP/ICH guidelines, and SOPs.
  • Work with project manager to develop training manuals and other study-related documents/tools.
  • Coordinate investigational drug shipments and product disposition. Provide timely and adequate distribution and return of drug supplies and other study-related supplies.
  • Work with site staff closely to meet target recruitment, standard quality, resolve data queries in a timely manner.
  • Write monitoring visit/contact reports, meeting minutes and investigator/site correspondence according to agreed project plan.
  • Maintain study files to ensure completeness and up-to-date of all essential documents at R&G and investigator sites.
  • Assist in protocol drafting and informed consent and case report forms development and approval.
  • Communicate progress of study and relevant information to Project Manager and other project team members. Assist Project Manager with additional responsibilities as required.
  • Assist in project manager to ensure study budget on track.
  • Mentor and coach junior CRA (senior CRA only)
  • Conduct co-monitoring (senior CRA only)
  • Provide input to study proposal as needed (senior CRA only)
REQUIREMENTS:
  • Above Bachelor Degree , Major in medical, pharmacy or related.
  • Above CET 4.
  • Good team player, self-motivated and attention to details.
  • Strong customer focused sense, towards internal and external customers.
  • Must be able to travel.
Location:
Beijing, Shanghai,Guangzhou
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