职位详情
Syneos FSP COS 临床试验助理(合同)
1.1-1.3万
赛纽仕医药咨询(上海)有限公司
北京
1-3年
本科
01-13
工作地址

平安国际金融中心

职位描述
招聘要求:
1.2-3年CTA工作经验,了解临床试验全流程
2.了解临床试验相关流程、GCP规范及行业基本规范要求
3.良好的跨部门跨团队沟通与协调能力
4.熟练使用microsoft office办公软件 (word, excel, PPT)
5.对合同工作有浓厚兴趣,工作耐心细致,逻辑清晰
6.具有主人翁意识,能够主动发现问题并积极推动解决问题
7.英文workable

优先考虑(prefer)
1. 法律、财务或相关专业背景
2. 有合同管理、付款流程管理等相关经验;
3. 参与过系统管理、流程优化等工作。

主要岗位职责
1. 熟悉并掌握临床试验合同的关键条款,明确可协商与不可修改条款的边界;
2. 审阅项目组往来邮件及合同;
3. 组织日常与法务团队协同开会,就需法务介入的协议条款进行讨论;
4. 与项目组沟通,了解site对合同条款提出修改的背景与诉求,必要时组织协调与项目组、法务及stakeholder开会讨论;
5. 了解相关职能部门就合同条款的责任,指引合同申请人取得相关职能部门的书面意见
6. 负责内外部沟通协调,确保合同流程高效推进;
7. 熟悉并遵循公司相关SOP;
8. 参与合同管理流程或系统优化,协助更新合同相关培训材料,并为内部/外部人员提供培训支持;
9. 维护临床试验合同及相关文件模板,更新SharePoint中的文档;
10. 完成上级交办的其他任务。

SUMMARY
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.
JOB RESPONSIBILITIES
• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training
QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)
• Bachelor degree or above
• Good communication and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 25% may be required

以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕

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