临床试验协调员 II
Clinical Trial Coordinator II
工作时间
标准（周一至周五）
工作环境
办公室
职位描述
目的：
为项目团队提供行政和技术支持。通过确保文件按照组织的SOP和部门指导文件中规定的日程进行审查，支持审计准备。为现场启动活动提供行政支持。协助在指定项目中制定现场启动的关键路径，以支持快速现场启动。代表公司在全球医学研究社区中进行交流。可能与研究人员和现场人员建立协作关系。通过与公司人员合作，建立各自市场中现场的知识库。可能在入职阶段担任导师。支持新员工的培训，并参与部门计划以帮助流程改进/优化。
核心职责
根据具体角色（中心或本地），协调、监督并完成分配试验的活动。
按照要求执行部门、内部、国家和研究人员文件审查，并在适当的系统中记录发现。
确保分配的任务按时、在预算内并以高质量标准完成。适时向项目负责人和直属经理主动沟通任何风险。
分析和核对研究指标。协助澄清和解决与现场文件相关的发现。
与内部部门和团队成员合作，为项目提供技术和行政支持。
保持对SOP、客户SOP/指令以及适用于所提供服务的现行法规指南的了解和理解。
确保与活动相关的试验状态信息在数据库中准确维护，并始终保持最新。
在适用的情况下，与客户当地分支机构建立和维护关系。
推动战略协作现场纳入流程。
对新员工进行流程和系统的培训。
可能支持特定研究的文档维护和全球支持，使用特定系统、工具和跟踪器，包括但不限于研究团队名单、项目特定培训需求跟踪、组织/供应商/客户的系统访问管理以及在适当系统中跟踪项目级活动计划。
可能负责翻译工作
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents the organization in the global medical research community. May develop collaborative relationships with investigators and site personnel. May develop a knowledge base of sites in the respective market through collaboratively working with company personnel. May act as a buddy during onboarding phase. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.
Essential Functions
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Analyzes and reconciles study metrics. Assists with clarification and resolution of findings related to site documentation.
Assists with technical and administrative support for projects in collaboration with internal departments and team members.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
Where applicable, develops and maintains relationship with client local affiliates.
Champions the inclusion of Strategic Collaboration sites into the process.
Trains new personnel in processes and systems.
May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system.
May transmit documents to client and centralized IRB/IEC.
May attend Kick off Meeting and take notes when required.
May support scheduling of client and/or internal meetings.
May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
Assists the project team with the preparation of regulatory compliance review packages.
May support start-up team in Regulatory submissions.
Occasionally works directly with site(s) to obtain documents related to site selection.
Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalates concerns/non-compliance to management.
Originally posted on Himalayas