職責：
? 臨床前文檔的準備工作；
? 試驗管理：協助研究者進行試驗管理，包括協調申報倫理、研究協議簽署等；
? 協助研究者的日常工作；
? 受試者管理；
? 協調CRA 到site 的例行訪視；
? 臨床試驗檔案管理：負責該中心的臨床試驗項目文件整理和歸檔；
? 協助完成臨床研究藥物管理和計數，包括藥物的接收、保存、分發、回收和歸還，并完成相關記錄；
? 會議支持：負責各項啟動會議、研究者會議的會務安排；
? 研究者指定的其它工作。
任職要求：
? 醫藥護相關專業，大專以上學歷；
? 一年CRC相關經驗以上者優先；
? 有良好的溝通能力，良好的服務意識和團隊協作精神
? 英語要有一定的讀寫能力。
Responsibility for SCRC/CRC
? 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.
? Thorough knowledge of CCBR procedures and quality control regulations (relevant for the Study Nurse position), which forms the basis of performing clinical studies.
? Knowledge of international/national regulations and instructions for performing clinical studies.
? Perform in a professional, kind and efficient manner, when taking care of study participants.
? Thorough knowledge to the content of the Study File and responsible for the document filling.
? Have a good grasp of the Patient File.
? Responsible for the content of the Patient File, general pages as well as study specific pages.
? Responsible for coordination concerning eligibility in the study enrolment phase.
? Update study staff members on current study procedures and other relevant information.
? Make appointments with Sponsors representative for monitoring.
? Always be updated on the current study status.
? Thorough knowledge of the time schedule.
? Handling of drug supplies.
? Handling of test results.
? Last check of Patient Files and CRF’s.
? To participate in and add information to planned clinic meetings.
? To participate in education and training planned by CCBR.
? To participate in arrangements planned by CCBR, with the purpose of nurturing the solidarity between individual demarcation groups and collaborating groups.
? To participate in subject recruitment program/community out reach.
? Participate in meetings arranged by Study Management Manager/GM; such as investigator meetings, initiation meetings etc.
Requirements:
? Medical and nursing related major, college degree or above;
? More than one year CRC related experience is preferred;
? Good communication skills, good service awareness and team spirit；
? Basic English reading and writing ability.