400-885-9898
职位描述
CTACRC药品临床研究生物药化学药新药医药制造医疗检测医疗设备/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:
Ø 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
Ø 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
Ø 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
职位福利：五险一金、年底双薪、交通补助、带薪年假、补充医疗保险、节日福利、弹性工作、定期体检
工作地点
北京朝阳区平安国际金融中心A座
相似职位
- 临床研究助理CTA8000-13000元·13薪
北京 - 朝阳
爱恩康临床医学研究(北京)有限公司 - Clinical Trial Assistant(CTA)8000-12000元·13薪
北京 - 朝阳
爱恩康临床医学研究(北京)有限公司 - 医学专员/主管1-2万·14薪
北京 - 朝阳
迈威(上海)生物科技股份有限公司北京分公司 - 医学专员/经理-北京2.2-3万·13薪
北京 - 大兴
北京合源汇丰医药科技有限公司 北京 - 朝阳
赛纽仕医药咨询(上海)有限公司- 医学研究员1.8-2.5万
北京 - 朝阳
博知同益(北京)医学科技有限公司
热门公司推荐
- 霸王茶姬招聘
- 肯德基招聘
- 顺丰招聘
- 美团招聘
- 京东招聘
- 饿了么招聘
- 比亚迪招聘
- 中国一汽招聘
- 北京汽车招聘
- 蔚来招聘
- 东风汽车招聘
- 长城汽车招聘
- 奇瑞汽车招聘
- 理想汽车招聘
- 长鑫存储招聘
- 天江药业招聘
- 蓝月亮招聘
- 安踏招聘
- TCL招聘
- 海信招聘
- 联想招聘
- 海康威视招聘
- 宁德时代招聘
- 中兴招聘
- 新松招聘
- 京东方招聘
- 申通招聘
- 圆通招聘
- 中通招聘
- 百世物流招聘
- 德邦物流招聘
- 麦当劳招聘
- 星巴克招聘
- 海底捞招聘
- 蜜雪冰城招聘
- 瑞幸招聘
- 雀巢招聘
- 腾讯招聘
- 百度招聘
- 快手招聘
- 字节跳动招聘
- 新华网招聘
- 小米招聘
- 招商银行招聘
- 中信银行招聘
- 北京银行招聘
- 兴业银行招聘
- 交通银行招聘
- 建发集团招聘
- 中国移动招聘
- 中国联通招聘
- 中国电信招聘
- 中粮集团招聘
- 国药控股招聘
- 中广核招聘
- 中国船舶招聘
- 强生中国招聘
- 汇丰中国招聘
- 宜家招聘
- 立邦中国招聘
- 伊利招聘
- 青岛啤酒招聘
- 京港地铁招聘
- 宝马招聘
- 小鹏汽车招聘
- 华为招聘
- 特斯拉招聘
- 吉利招聘
- 奔驰招聘
- 海尔招聘
- 美的招聘
- 京东方招聘
- 施耐德电气招聘
- 德邦物流招聘
职位发布者
郭玉玲/人事经理
三日内活跃立即沟通
爱恩康临床医学研究(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.
公司主页