现场管理助理 I
Site Management Associate I
我们是一家注重员工、客户、合作伙伴以及工作质量的公司。一家成立于1995年的充满活力的全球性企业，我们汇聚了超过2,800名有动力、有奉献精神且充满热情的个人。我们在医学科学的最前线工作，改变人们的生活，将新药带给需要的人。
加入我们的国际团队，成为临床研究项目的重点支持人员，优化沟通，维护系统并管理文件和信息。
仅接受英文简历。
您将负责：
· 作为项目中现场人员与CRA之间的主要联系人，协助解决疑问和完成EDC。
· 作为供应商、研究物资和访问管理的主要现场联系人。
· 确保本地现场设施的预研究测试（扫描、MRI/CT资格问卷、测试心电图等）完成。
· 协助监查员及时在CTMS中完成所有受试者事件和现场事件信息。跟踪CTMS中现场问题和行动项的解决状态。
· 负责临床物资的订购、接收、库存存储、分发、退回/召回和对账。
· 确保监管和伦理委员会的提交和通知，这意味着您需要了解当地的法规和要求。
· 协调现场、TMF和系统的审计和检查的准备及后续工作。
· 在现场和国家层面管理TMF，定期归档文件。准备、分发和更新研究者现场文件（ISF）和ISF检查清单。
· 安排并跟踪现场团队在所有供应商相关系统中的初始和持续培训。
· 文档管理和研究翻译状态的审查。
· 确保与研究现场之间安全信息的正确传递。
- 生命科学专业本科/大学学位；
- 行政工作经验，最好是在国际环境中；
- 有在CRO担任CTA的经验；
- 有临床研究工作经验；
- 了解当地法规；
- 英语流利；
- 熟练使用MS Office应用；
- 能够在动态团队环境中计划和工作；
- 沟通和协作能力。
在临床研究领域提升您的职业生涯，协调各种任务，在不断学习中与公司共同成长。
查看英文原文
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
Only CVs in English will be accepted.
You will be responsible for:
· Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
· Serves as the primary sites’ contact point for vendors, study supplies, and access management.
· Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
· Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
· Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
· Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
· Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
· Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
· Arrange and track initial and on-going project training for site teams in all vendor-related systems.
· Document Management and translations status review of the study.
· Ensures proper safety information flow with investigative sites.
- College/University Degree in Life Sciences;
- Administrative work experience, preferably in an international settings;
- Prior experience working as CTA for CROs;
- Prior experience working in Clinical Research;
- Local regulations knowledge;
- Full working proficiency in English;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.