职责：

Ø 临床前文档的准备工作；

Ø 试验管理：协助研究者进行试验管理，包括协调申报伦理、研究协议签署等；

Ø 协助研究者的日常工作；

Ø 受试者管理；

Ø 协调CRA 到site 的例行访视；

Ø 临床试验档案管理：负责该中心的临床试验项目文件整理和归档；

Ø 协助完成临床研究药物管理和计数，包括药物的接收、保存、分发、回收和归还，并完成相关记录；

Ø 会议支持：负责各项启动会议、研究者会议的会务安排；

Ø 研究者指定的其它工作。

任职要求：

Ø 医药护相关专业，大专以上学历；

Ø 一年CRC相关经验以上者优先；

Ø 有良好的沟通能力，良好的服务意识和团队协作精神

Ø 英语要有一定的读写能力。

Responsibility for SCRC/CRC

Ø Knowledge of the protocols and through knowledge of the examinations and procedures in connection with the Study Nurse position as discussed in the protocols and in accordance with the study specific defined responsibility log.

Ø Thorough knowledge of CCBR procedures and quality control regulations (relevant for the Study Nurse position), which forms the basis of performing clinical studies.

Ø Knowledge of international/national regulations and instructions for performing clinical studies.

Ø Perform in a professional, kind and efficient manner, when taking care of study participants.

Ø Thorough knowledge to the content of the Study File and responsible for the document filling.

Ø Have a good grasp of the Patient File.

Ø Responsible for the content of the Patient File, general pages as well as study specific pages.

Ø Responsible for coordination concerning eligibility in the study enrolment phase.

Ø Update study staff members on current study procedures and other relevant information.

Ø Make appointments with Sponsors representative for monitoring.

Ø Always be updated on the current study status.

Ø Thorough knowledge of the time schedule.

Ø Handling of drug supplies.

Ø Handling of test results.

Ø Last check of Patient Files and CRF’s.

Ø To participate in and add information to planned clinic meetings.

Ø To participate in education and training planned by CCBR.

Ø To participate in arrangements planned by CCBR, with the purpose of nurturing the solidarity between individual demarcation groups and collaborating groups.

Ø To participate in subject recruitment program/community out reach.

Ø Participate in meetings arranged by Study Management Manager/GM; such as investigator meetings, initiation meetings etc.

Requirements:

Ø Medical and nursing related major, college degree or above;

Ø More than one year CRC related experience is preferred;

Ø Good communication skills, good service awareness and team spirit；

Ø Basic English reading and writing ability.