职位描述: JOB PURPOSE:
The main tasks of the Clinical Project Assistant (CPA) are the administrative support of the set-up, monitoring and reporting of clinical trials in conformity with Good Clinical Practice and Sanofi-Synthelabo’s internal Standard Operating Procedures in order to facilitate to a high extent the execution of the research projects.
KEY ACCOUNTABILITIES:
1.The efficient and accurate administrative processing of forms concerning data collection, medication and other materials with regard to clinical trials. Activities are based on the guidelines as described in Sanofi-Synthelabo’s Standard Operating Procedures.
2.Set up, manage and keep up-to-date the trial archives in accordance with the Sanofi-Synthelabo Standard Operating Procedures for filing of trial documents (among which the so-called “core file”) in such a way that any relevant information can be presented promptly during internal or external audits.
3.Be an internal focal point for the Clinical Research Associates and Clinical Research Physicians working on-site.
4.Communicate with external relations on a professional level.
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
Experience & knowledge:
Good working knowledge of all relevant Standard Operating Procedures and guidelines with regard to Good Clinical Practice.
Core competencies:
-Excellent communicative skills and a professional attitude
-Common sense, efficiency and flexibility
-Has an eye for details
-Fluency in English, spoken and in writing
-Adequate knowledge of common softwares is required.
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