Start-up Specialist I/II 上海

月薪： 1.5千以下/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 12-12 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： Job Summary:Primary contact with assigned investigative site(s) during site start-up (SSU) activities with responsibility for collection of the required investigator and regulatory documents for a study, to ensure EC applications are made within the timelines agreed with project management and SU team and that documentation meets the specifications required by applicable regulations and sponsor.Ensures Covance systems accuracy, reflecting site readiness to enroll. Ensures clinical sites are ready for the first day that the drug trial begins. The job holder performs the above with some supervision.Maintains allocated site’s information and associated regulatory documents throughout the duration of the clinical trial.Essential Job Duties:1. Provide local support for clinical trial supply coordination, if applicable.2. Ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.3. Collect, review, process, and track regulatory & investigator documents required for effective and compliant study site activation.4. Ensure that all assigned start up activities are on track and support study deliverables.5. Proactively manage sites to ensure timely site activation.Participate in team meetings to progress trials and identify site issues that might impact the timelines.6. Escalate study issues appropriately and in a timely fashion.7. When needed, assist in preparation of Site Activation project specific plans. Provide accurate projections and timelines to study teams agreed with Sponsor.8. Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol.9. Review and update study documents when there are changes in study personnel/study amendments.10. Liaise with Covance Regulatory department regarding document submission requirements, if applicable.11. Proactively resolve informed consent issues and other potential difficulties with study sites.12. Prepare submissions to IRB/IEC, and regulatory authorities if GRS requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/approval issues.13. Ensure high quality site documents are filed in the (e)TMF in a timely manner according to study plans.14. Negotiate site contracts and budgets with sites, if applicable.Proactively track progress of contract and budget milestones/developments, intervening and escalating as appropriate.15. Undertake tasks delegated by senior team members, depending upon country and situational requirements.16. Perform other duties as assigned by management.Education / Qualifications:University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.Experience :1. Minimum of 2 years of experience in clinical development or regulatory process is preferred.2. CTA,CRC,CRA etc experiences are preferred3. Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations / guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites. Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them工作地址上海office-普陀区； 广州office-天河区； 北京office-朝阳区 职能类别： 临床协调员

联系方式

岚皋路555号

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

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