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Clinical Research Associate 〔FESCO HIRE)

 
岗位信息
  • 更新时间:2016-02-29
  • 学历:本科
  • 工作地点:北京市
  • 语言要求:英语
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:
岗位要求
岗位职责:



Responsibilities
PRIMARY RESPONSIBILITIES:
-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.

Qualifications
ESSENTIAL REQUIREMENTS:
-Bachelor degree or above at Medicine or related field.
-With experience in clinical practices including site management and project management preferred.
-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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