職責(zé)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 Team 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.

• Additional tasks assigned by manager, include but
  not limited: study level tasks associated with Country Study Manager
  (CSM), act as a mentor for junior team member, co-monitor less experience
  CRA within study team.


• Contribute to process improvements, knowledge
  transfer and best practice sharing.

任職資格：

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

· Minimum 3-year experience as CRA or other related fields.

· Have proven track record on performance of site management
and monitoring delivery.

· Solid understanding of the clinical dataflow

· Excellent 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.

· Good knowledge of the Monitoring Process, such as understanding of the
Study Drug Handling Process and the Data Management Process, etc.

· Demonstrates ability to prepare and deliver study related training
materials

· Ability to look for and champion more efficient and effective methods/processes
of delivering quality clinical trials with reduced budget and in less time.

· Very good written and verbal communication skills, negotiation,
collaboration and interpersonal skills.