RSU I , China , Hongyi Team

RSU I , China , Hongyi Team Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies . With over 25 years of experience and a world-renowned focus in renal research , Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role The Regulatory Start-Up Specialist I (RSU Specialist I) performs tasks associated with Regulatory, Start-up and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site selection activities. RSU启动专员根据适用的本地和/或国际法规，标准操作程序（SOP），项目要求和合同/预算指南，执行与监管，启动和研究中心维护活动相关的任务。可能参加可行性调研和/或研究中心筛选活动。 Responsibilities · 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. · 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。 · 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. · 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. · 准备现场监管文件，审查完整性和准确性。 · Review, prepare and negotiate site contracts and budgets with sites, if applicable. · 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）。 · Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. · 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。 · Review and provide feedback to management on site performance metrics. · 审查并提供有关研究中心绩效指标管理的反馈。 · Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. · 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. · 通知团队成员完成单个研究中心的监管和合同文件。 · 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. · 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。 · Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning. · 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。 · Perform quality control of documents provided by sites. · 对研究中心提供的文件进行质量控制。 · May have direct contact with sponsors on specific initiatives. · 必要时与申办方直接联系具体措施。 · May perform Site Selection Visits if a trained monitor. · 作为接受培训的监查员，可以执行研究中心筛选访视。 · May participate in feasibility and/or site identification activities. · 可参加可行性和/或研究中心评估工作。 · May participate in EC submission, contract negotiation with site. · 可参加研究中心伦理文件递交、与研究中心进行合同谈判。 About You In-depth knowledge of clinical systems, procedures, and corporate standards. 深入了解掌握临床系统、工作流程和公司的标准。 Demonstratesthoroughknowledgeofclinicalresearch industrystandards, practices,and regulations 能充分理解和应用临床试验的标准，实践和法规。 Exhibitsgooddecisionmakingskillsutilizingall availableresourcesfordeterminingpositiveoutcomes. 为了追求积极的成果，能利用所有可能的资源进行决策判断。 Ability to work on multiple projects. 能为多个项目工作 Effective communication, organizational, planning and interpersonal skills 有效沟通、组织、计划和人际交往能力 Problem solving, Fact Finding & Analysis 问题的分析与解决能力 Understanding of regulated clinical trial environment and knowledge of drug development process 理解临床试验政策法规环境和药物开发过程的知识 Seeks assistance for more complex issues. 当遇上更为复杂的问题时，寻求帮助。 Ability to establish and maintain effective working relationships with coworkers, managers and clients. 与同事、经理和客户能建立和维护有效的工作关系 Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work : You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise : Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience. • Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates. Department Clinical Operations Locations China - Guangzhou, China - Shanghai, China - Wuhan, China - Shenyang, China - Harbin Remote status Hybrid