[天津]上海切尔西医药科技咨询有限公司天津总医院

职位名称：临床研究协调员

 

工作地点：天津总医院

 

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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