Clinical Research Associate 〔CRA) / Senior Clinical Research Associate 〔SCRA)-Hired through Fesco

  • 更新时间:2016-02-29
  • 学历:本科
  • 工作地点:湖北省-武汉市
  • 语言要求:
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:

- Assist Project Leader and Clinical Research Manager with the identification and selection of investigators to undertake clinical studies, when required.
- Assist Project Leader and Clinical Research Manager with preparation of study budget.
- Prepare documentation for Ethics Committee submission.
- Coordinate receipt and distribution of clinical trial supplies.
- Prepare and conduct initiation visits.
- Oversee assigned clinical trials to ensure compliance with the highest standards of GCP and according to Pfizer’s SOPs.
- Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel.
- Liaise with and report to Project Leader/SM regularly on study status through monitoring reports and meetings.
- Document all study related communications.
- Perform Source Data Verification to ensure accurate data is recorded.
- Ensure all Serious Adverse Events are reported and followed up according to Pfizer SOPs.
- Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.
- Ensure documentation is maintained according to Pfizer SOPs.
- Track study payments to ensure payments are on time and within budget.
- Coordinate the resolution of data queries and their return to Pfizer in a timely manner.
- Perform study closeout visits at the completion of database lock.

- Bachelor degree or above at Medicine or related field.
- At least two year experience in clinical practices including site management and project management.
- Good working knowledge of GCP guidelines.
- Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
- Knowledge of drug development process.
- Knowledge of clinical trial methodology.
- Result oriented.
- Customer focus and teamwork.
- Organizational commitment.
- Good communication skill.



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