中心启动专员RSU 8k-10k

工作职责:
61 Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
61 在一般管理情况下，作为研究中心调研、RSU团队负责人，临床操作，可行性调研，研究中心评估，项目领导的单点联系人（SPOC）开展工作。确保遵守标准操作程序（SOP），工作指南（WI），指定可交付成果的质量以及项目时间表。
61 Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
61 根据适用的法规，SOP和工作指导执行监管，启动和维护活动。 将完成的文件分发到站点和内部项目组成员。Prepare site regulatory documents, reviewing for completeness and accuracy.
61 准备现场监管文件，审查完整性和准确性。
61 Review, prepare and negotiate site contracts and budgets with sites, if applicable.
61 对研究中心合同和预算进行审查，准备及与研究中心谈判（如适用）。
61 Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
61 确保具有项目特定信息的内部系统，数据库和跟踪工具准确完成和维护。
61 Review and provide feedback to management on site performance metrics.
61 审查并提供有关研究中心绩效指标管理的反馈。
61 Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
61 审查，确定和商定项目规划和项目时间表。 确保监查措施到位，并根据需要实施应急预案。Inform team members of completion of regulatory and contractual documents for individual sites.
61 通知团队成员完成单个研究中心的监管和合同文件。
61 Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
61 根据项目时间表，审查，跟踪和跟踪进度，批准和执行文件，包括合同，监管，道德，ICF和IP版本文件。
61 Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
61 在初期和持续的项目时间表计划中，向RSU领导和项目团队提供本地经验。
61 Perform quality control of documents provided by sites.
61 对研究中心提供的文件进行质量控制。
61 May have direct contact with sponsors on specific initiatives.
61 必要时与申办方直接联系具体措施。
61 May perform Site Selection Visits if a trained monitor.
61 作为接受培训的监查员，可以执行研究中心筛选访视。
61 May participate in feasibility and/or site identification activities.
61 可参加可行性和/或研究中心评估工作。
61 May participate in EC submission, contract negotiation with site.
61 可参加研究中心伦理文件递交、与研究中心进行合同谈判。


任职资格:
Education教育
61 Undergraduate degree or its international equivalent in clinical, life science, or health related field from an accredited institution or a licensed healthcare professional
本科学历及以上或具有国际认证的同等学历，临床、生命科学或卫生相关专业。
Experience经验
61 Half of year’s clinical research or other relevant experience, or equivalent combination of education, training and experience.
至少0.5年以上临床试验相关工作经验，或等同的综合教育、培训和工作经验
Language语言
61 Read, write, and speak fluent English; fluent in host country language required
英语听，说，写达到流利；母语沟通能力流利。