SCRA

1、负责立项伦理申请、合同签署、遗传办备案、临床试验备案、启动会、制临床试验监察、结题关中心全流程。

Responsible for the whole process of project ethics application, contract signing, genetic office filing, clinical trial filing, launch meeting, clinical trial supervision and closing center.

2、协助临床医院筛选；协助临床试验方案、研究者手册、临床小结、总结报告的撰写。

Assist clinical hospital screening; Assist in the preparation of clinical trial protocols, investigator manuals, clinical summaries and summary reports.

3、与CRO公司、数据管理和统计公司对接。

Interface with CRO companies, data management and statistics companies

4、负责临床试验的监查工作，制定监查计划，完成监查报告，确保试验严格按照临床试验方案、相关法规进行。

Responsible for the monitoring of clinical trails.Develop a monitoring plan, Complete the monitoring report.To ensure the clinical trails is conducted in strict accordance with regulations and clinical protocol.

5、负责临床试验中心试验仪器、试剂、耗材、文件的协调和管理。

Responsible for the coordination and management of test instruments, reagents, consumables and documents in the clinical trial center.

6、接受上级领导安排的其他工作任务。

Accept other tasks assigned by superiors.

任职要求

1、本科及以上，检验医学、临床医学，生物，医药等相关专业背景。

Bachelor degree or above, Major in Laboratory medicine ,Biology,Clinical medicine

2、有3-5年及以上体外诊断试剂临床试验CRA工作经验，具有三类项目经验。有流式细胞仪操作经验者优先。

More than 3 to 5 years CRA working experience，Experience in three types of IVD reagent projects。Experience in flow cytometer operation is preferred.

3、了解临床数据，有统计学专业知识。

Professional knowledge in statistics.

4、熟悉GCP要求，熟悉医院工作流程，能适应长时间出差。

Familiar with GCP,familiar with the hospital workflow,and able to long time travel.

5、工作认真，具有组织、协调、沟通能力，具有独立解决问题的能力，有责任心，具有职业素养。

Word hard,strong organization coordination,communication and negotiation skills. Have a strong sense of responsibility,have professional accomplishment.

Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, ***, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.