職責(zé):
? 臨床前文檔的準(zhǔn)備工作;
? 試驗(yàn)管理:協(xié)助研究者進(jìn)行試驗(yàn)管理,包括協(xié)調(diào)申報(bào)倫理、研究協(xié)議簽署等;
? 協(xié)助研究者的日常工作;
? 受試者管理;
? 協(xié)調(diào)CRA 到site 的例行訪視;
? 臨床試驗(yàn)檔案管理:負(fù)責(zé)該中心的臨床試驗(yàn)項(xiàng)目文件整理和歸檔;
? 協(xié)助完成臨床研究藥物管理和計(jì)數(shù),包括藥物的接收、保存、分發(fā)、回收和歸還,并完成相關(guān)記錄;
? 會(huì)議支持:負(fù)責(zé)各項(xiàng)啟動(dòng)會(huì)議、研究者會(huì)議的會(huì)務(wù)安排;
? 研究者指定的其它工作。
任職要求:
? 醫(yī)藥護(hù)相關(guān)專業(yè),大專以上學(xué)歷;
? 一年CRC相關(guān)經(jīng)驗(yàn)以上者優(yōu)先;
? 有良好的溝通能力,良好的服務(wù)意識和團(tuán)隊(duì)協(xié)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.
職位福利:五險(xiǎn)一金、績效獎(jiǎng)金、交通補(bǔ)助、餐補(bǔ)、通訊補(bǔ)助、帶薪年假、定期體檢、節(jié)日福利