cta岗位职责

协助完成临床试验项目的资料收集、整理和归档管理
协助完成临床试验项目合同，付款等工作
协助完成临床试验物资的准备
协助完成临床试验伦理资料的准备
协助组织项目会议，撰写会议记录

FSP项目外派Global Pharm
Candidates familiar with VBA other automation technical skills (such as Power Apps, Power Automate, Python, etc)
Essential Job Duties:
1) Document track study activities using relevant forms tools, as well as relevant Project Management Systems with guidance/support
2) Assist in the preparation of study site specific materials in accordance with relevant SOPs
3) Complete minute taking documentation fsponsor/external internal teleconferences as requested
4) Assist in setting up maintaining tracking systems/spreadsheet fe.g. study supplies
5) Maintain the Project Directory
6) Provide support fInvestigatMeetings; track meeting attendees and/other information regarding the InvestigatMeeting
7) Provide support to project team (e.g. proof-reading editing correspondence, mailings, shipping of study files, faxing photocopying
documents, assembling study documents, arranging meetings, etc.)
8) Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, track /archive
as applicable
9) Audit CAPA tracking
10) Set up maintain clinical investigatfiles documentation
11) Liaise with vendors, as needed, fstudy conduct such as printing study materials and/external systems access fstudy team members.
• Coordinate plan study supply shipments with vendors
• Maintain confirm shipment information such as courier tracking numbers date of shipping delivery
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e. diary cards, patient visit reminders).
12) Generate reports as needed, fexample CTMS site contact information list
13) Work with the In-House CRA other project team members on reconciliation of data with CTMS.
14) General communications to sponsors, sites internal team members via electronic mail courier telephone
15) Perform other administrative duties as assigned by Line Manager, Project Managers Clinical Trial Lead.
Requirement:
•Minimum one (I) year administrative experience equivalent training
•Goodal written communication skills
•Goodganizational time management skills
•Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
Preferred:
•Aptitude fhandling proof-reading numerical data, some spreadsheet software competency
•Good typing skills
•Good spelling proof-reading skills
•Ability to operate standard office equipment (e.g., fax, copier)
•Works efficiently effectively in a matrix environment
• University college degree, certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough knowledge of ICH Guidelines understanding of local regulatory requirements
• Thorough knowledge of monitoring procedures
• Basic understanding of the clinical trial process
• Valid Drivers License

岗位目的
1. 协助临床项目经理和临床监查员完成内部工作流程的执行，确保项目的顺利开展。
2. 协助模块CTA处理模块工作中的相关工作内容。
主要工作职责
一、项目CTA工作
1. 负责伦理资料的准备。
2. 审核研究中心合同，完成内部流程的签署。
3. 负责研究中心付款的审核和申请，以及研究中心物资的准备和发放。
4. 协助项目经理完成文档的回收、检查、登记和追踪。
5. 协助项目经理组织和召开项目会议，帮助项目经理追踪项目相关工作等。
6. 根据项目需要完成项目经理安排的其他工作。
7. 跟进CTA小组的要求，必要时对PM和CRA进行培训。
二、模块CTA工作
1. 协助主管完成模块工作中的相关工作内容（模块工作主要包括但不限于以下板块：网址公示、人类遗传资源管理的申报、省局备案、部门行政事务、药物供应、物资供应、伦理递交管理、研究中心合同管理、付款流程管理、SAE理赔管理、Etmf&SSF管理、申报资料附件整理、研究者会议组织和支持、平台管理和培训等。根据小组工作安排，可能会被安排到管理某个或者某几个模块）。
2. 负责模块工作中的具体工作的执行和汇总。
3. 汇总模块工作中的共性问题并给予反馈。
任职要求：
1. 大专或本科学历，临床医学、制药、生物技术或英语相关专业，1年以上相关经验。
2. 专业知识：了解GCP、相关法规指南、医药基础知识
3. 技能要求：具备较好的信息收集能力，以及熟练使用办公软件
4. 其他要求
具备良好的服务意识以及较强的应变能力
具备较强的独立工作能力和团队合作精神
关注细节，具有良好的执行力
良好的表达能力、沟通和协调能力