临床监查员 II（外派外资药厂）

职责要求：

• Drive 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
  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 Delivery Team Lead and QA.

·
任职资格：

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

· Minimum 2-year
experience as CRA or other related fields. Experience as a clinical monitor,
performed all tasks for a CRA position.

• Knowledge of the Monitoring Process, such as
  understanding of the Study Drug Handling Process and the Data Management
  Process, etc.

· Understanding of the clinical dataflow
· Solid 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.