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復(fù)星醫(yī)藥 · 北京復(fù)星醫(yī)藥

臨床研究助理(CTA)(J12759)

薪資面議  /  北京,、上海

2025-04-23 更新

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職位屬性

  • 招聘類型:社招
  • 工作性質(zhì):全職

職位描述

1 Responsible for managing and archiving of clinical trial documents in collaboration with CRA and project leader in accordance with departmental SOP, including but not limited in collecting, uploading and maintenance.

遵守部門的SOP,,負(fù)責(zé)臨床試驗(yàn)中文件的管理,,包括但不限于臨床試驗(yàn)文件的收集、整理,、上傳,、審核、歸檔等,。

2 Support contracts and other documents process: both online and offline.

支持項(xiàng)目合同以及各類文件的簽字,、蓋章流程:包括線上及線下流程。

3 Support GCP office and EC dossiers preparation: including printing, stamping and expressing.

協(xié)助項(xiàng)目組準(zhǔn)備,、制作立項(xiàng)及倫理文件夾:包括打印,、蓋章、郵寄等,。

4 Support study teams develop and coordinate to manage the study budget, to ensure study payments are paid on time and the invoices are collected meeting financial requirements.

協(xié)助項(xiàng)目組管理項(xiàng)目費(fèi)用,,保證所有費(fèi)用及時支付,發(fā)票按時回收并提交財(cái)務(wù),。

5 Supports electronic Trial Master Files (eTMF) QC as needed.

按照項(xiàng)目組的要求,,對項(xiàng)目組上傳至eTMF的文件進(jìn)行核對。

6 Support the application of various system accounts and the management.

協(xié)助項(xiàng)目組申請及維護(hù)系統(tǒng)賬號,。

7 Support study team organizing internal meetings; provides enough logistic supports for investigator meetings and inspections.

協(xié)助項(xiàng)目組組織各種內(nèi)部會議,;支持外部活動,如研究者會及項(xiàng)目核查等,。

8 According to the project requirements, complete the designated administrative work during the project, and provide support to team members in the execution of clinical trials.

根據(jù)項(xiàng)目的需要,,完成行政類工作的支持。

9 Update and maintain internal databases, study related systems and study plans with study specific information.

整理項(xiàng)目的數(shù)據(jù)及信息,,協(xié)助更新及維護(hù)內(nèi)部數(shù)據(jù)庫,。

10 Support meetings/events or complete other tasks assigned by department head, line manager.

支持部門的會議/活動,完成直線經(jīng)理或部門負(fù)責(zé)人安排的其他工作,。

任職條件

Bachelor degree or above, major is not limited, clinical pharmacy, nursing or related major is preferred.

本科及以上學(xué)歷,,專業(yè)不限,臨床醫(yī)學(xué),、藥學(xué),、護(hù)理學(xué)或相關(guān)專業(yè)優(yōu)先。

 

At least 1.5 year of CTA experience; experience in Biotech or sponsor is preferred.

1.5年以上CTA相關(guān)工作經(jīng)驗(yàn),,有創(chuàng)新型生物醫(yī)藥公司或申辦方工作經(jīng)驗(yàn)優(yōu)先,。也可接受優(yōu)秀應(yīng)屆畢業(yè)生

 

? Familiar with Chinese Good Clinical Practice (GCP) and ICH-GCP and related regulations.

? 熟悉GCP及相關(guān)法規(guī)。

? Computer skill including proficiency in use of Microsoft word, Excel, etc.

? 熟練掌握各類辦公軟件,。

? Strong sense of responsibility and communication skills, be able to arrange and handle multiple-tasks, good team spirit and pressure resistance ability.

? 有責(zé)任心,,溝通能力強(qiáng),,能夠合理安排及處理多項(xiàng)目工作,有良好的團(tuán)隊(duì)精神及抗壓能力,。

職位要求

  • 學(xué)歷要求:本科

公司福利

  • 五險一金
  • 餐費(fèi)補(bǔ)貼
  • 交通/通訊津貼
  • 年度團(tuán)建
  • 員工體檢
  • 商業(yè)保險
  • 年休假
  • 職業(yè)發(fā)展雙通道
  • 發(fā)展空間大