职责要求：

• Drive study performance at the sites. Perform
  site monitoring and other onsite visit activities according to monitoring
  plan and in compliance with procedural documents. Provide the required
  monitoring visit reports within required timelines. Proactively identify
  study-related issues and escalates to Local Study Teams as appropriate.


• Contribute to the selection of potential sites
  and investigators. Train, support and advise Investigators and site staff
  in study related matters.


• Obtain and maintain essential documentation in
  compliance with ICH-GCP, Procedural Documents and local regulations.
  Manage study supplies (ISF, CRF, etc), drug supplies and drug
  accountability at study sites.


• Perform source data verification according to SDV
  plan. Ensure data query resolution. Work with data management to ensure
  quality of the study data.


• Ensure accurate and timely reporting of Serious
  Adverse Events.


• 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.


• Prepare for activities associated with audits and regulatory
  inspections in liaison with local Study Team Lead and QA.

任职资格：

· Bachelor degree in biological science or healthcare-related
field., or equivalent

· Less than 2-year experience as a clinical monitor, performed
all tasks for a CRA position or joined CRA trainee program or equivalence.

· Understanding of the clinical dataflow.

· Good knowledge of the clinical study and drug development processes,
GCP/ICH guidelines and relevant local regulations.

· Good computer skills in Microsoft and other
software.

· Fluent in both oral and written English.

· Proficient written and verbal communication skills, collaboration and
interpersonal skills.