職位描述
CTACRC藥品臨床研究生物藥化學藥新藥醫藥制造醫療檢測醫療設備/器械
Primary Function:
The Study Team Associate (STA) is a member of clinical trial team supporting delivery of clinical studies within ZaiLab to ensure the operational deliveries are executed with expected timeline, satisfying quality, and approved budget, from Protocol development through study set-up, maintenance, close-out, and study archiving.
The STA supports Study Team Leader (STL) in delegated activities and provides technical, administrative, and logistical support to ensure efficient execution of clinical trials, in line with ICH/GCP, ZaiLab SOP and regulatory regulations.
The STA supports Study Team Leader (STL) in delegated activities and provides technical, administrative, and logistical support to ensure efficient execution of clinical trials, in line with ICH/GCP, ZaiLab SOP and regulatory regulations.
Major Responsibilities and Duties:
- Complete the delegated tasks under the guidance from STL
- Expected to work on the tasks assigned in less complicated clinical trials independently
- 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
- Create and maintain the communication platforms (MS Team, SPOL, Group email list, etc) for the whole study team
- Control the access of systems deployed to a specific study, include but not limited to IxRS, EDC, CTMS and eTMF
- Support clinical trial registration and disclosure on public portal according to the requirement of regulatory authorities
- Involved in the submission package preparation (including HGR Submission) by working closely with STL, CRAs and functional stakeholders
- Contribute to the clinical trial documents development, such as study protocol, ICF, study results report and management plan per STL assignment
- 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
- 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
- Support goods purchase, document delivery, devices shipment and recycle during the conduct of clinical trial
- 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
- 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
- Draft and distribute the newsletters/communication letters/presentation materials to internal and external stakeholders
- Complete delegated tasks during the audit and inspection by regulatory authorities
Qualifications:
? Educational Background
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
? Working Experiences and Competencies
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
? Working Experiences and Competencies
- Proven organizational and presentation skills
- Ability to manage multiple tasks and meticulous attention to detail
- Quick learner, good team player
- Excellent written and verbal communication skills
- Good written and spoken English
- Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint and Outlook, etc
- Good knowledge of ICH-GCP, 1-year Experience as CTA, CRC, or other roles in the clinical trials is preferable
職位福利：五險一金、年底雙薪、交通補助、帶薪年假、補充醫療保險、節日福利、彈性工作、定期體檢
工作地點
北京朝陽區平安國際金融中心A座
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職位發布者
郭玉玲/人事經理
昨日活躍立即溝通
愛恩康臨床醫學研究(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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