「北京朝陽區(qū) Study Team Associate (CTA)招聘」_2025年愛恩康臨床醫(yī)學(xué)研究(北京)有限公司招聘-智聯(lián)招聘

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Study Team Associate (CTA)

8千-1.2萬·13薪

北京朝陽區(qū)
經(jīng)驗不限
本科
全職
招2人

職位描述

CTA臨床試驗助理臨床試驗CRO

Major Responsibilities and Duties:

1、Complete the delegated tasks under the guidance from STL.

2、Expected to work on the tasks assigned in less complicated clinical trials independently.

3、Lead the set-up of electronic Trial Master Files (eTMF) system, Clinical Trial Management System (CTMS). And keep the information updated during course of the study per. requirement of the International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and ZaiLab SOP.

4、Create and maintain the communication platforms (MS Team, SPOL, Group email list, etc) for the whole study team.

5、Control the access of systems deployed to a specific study, include but not limited to IxRS, EDC, CTMS and eTMF.

6、Support clinical trial registration and disclosure on public portal according to the requirement of regulatory authorities.

7、Involved in the submission package preparation (including HGR Submission) by working closely with STL, CRAs and functional stakeholders.

8、Contribute to the clinical trial documents development, such as study protocol, ICF, study results report and management plan per STL assignment.

9、Responsible for overall TMF library healthy status. Guide study team members. (functionals and CRAs) on the eTMF/paper TMF documents transfer & archival, and lead Quality Check (QC) per TMF Plan.

10、Contribute to the finance related activities such as contract sign-off, IO & PO set-up, invoice process, budget tracker maintenance and reconciliation, including sites and third-party vendors.

11、Support goods purchase, document delivery, devices shipment and recycle during the conduct of clinical trial.

12、Coordinate and arrange the internal and external meetings, include but not limited to study team meetings, vendor defense meetings, investigator meetings, committee review meetings. And take meeting minutes/record if necessary.

13、Compile and maintain the clinical trial related lists and logs, include but not limited to study document version tracker, decision & issue & risk log, study contact list, Q&A log, vendor & system list, study specific training log.

14、Draft and distribute the newsletters/communication letters/presentation materials to internal and external stakeholders.

15、Complete delegated tasks during the audit and inspection by regulatory authorities.

Qualifications:

1、Proven organizational and presentation skills.

2、Ability to manage multiple tasks and meticulous attention to detail.

3、Quick learner, good team player.

4、Excellent written and verbal communication skills.

5、Good written and spoken English.

6、Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint and Outlook, etc.

7、Good knowledge of ICH-GCP, 1-year Experience as CTA, CRC, or other roles in the clinical trials is preferable.

8、Bachelor’s degree or above (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

職位福利：節(jié)日福利、五險一金、交通補(bǔ)助、餐補(bǔ)

工作地點

合生匯寫字樓北京市朝陽區(qū)西大望路甲22號院合生匯寫字樓4F-10

完善一份簡歷
616萬+企業(yè)在線搜索，780萬+海量職位精準(zhǔn)推薦

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愛恩康臨床醫(yī)學(xué)研究(北京)有限公司

At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.

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