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职位:临床研究协调员CRC
发布时间:2012-12-17
工作地点:其它
信息来源:福建中医药大学
职位类型:全职
职位描述
职位名称:临床研究协调员CRC

工作地点:福建三甲医院

工作时间:福州—全职(周一~周五)

学历要求:本科及本科以上

专业要求:临床、护理、临床药学、药学、预防医学等相关医学类专业

语言要求:大学英语四级/六级

有兴趣的同学可以把简历投到:hr@

职位描述

Responsibility:

- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-GCP and as required by the SOPs and study protocol;

- To participate in the recruitment and screening of research patients;

- To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution;

- To collect, prepare and submit of regulatory documents as per required by the site EC;

- To attend site initiation meeting;

- To prepare the documents for study monitor site visits;

- To assist investigator in obtaining proper written consent from each study participant according to the requirement;

- To perform functions necessary for completion of protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits;

- To complete and correct case report forms ensuring accuracy of all records connected with each

research patients;

- To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor;

- To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients;

- To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal

laboratory values and adverse events;

- To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members;

- To update the TMFs and ensure the accuracy and completeness of TMFs;

- To perform other duties as required.

Requirements:

- Bachelor or above Degree in Medicine or Nursing is a MUST;

- Familiar with hospital environment;

- Excellent communication skills with doctors and patients;

- Detailed orientated;

- Organizational skills;

- Ability to multi-task;

- Can work under pressure;

- Doctor or nurse who has digestive experience and is interested in clinical research is preferred.

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