岗位职责:

1. 监查和数据管理：CRA负责按照研究方案和GCP（Good Clinical Practice）规范，对临床试验项目进行全面的监查，确保数据的真实性、准确性和完整性。这包括中心筛选、立项、伦理审查、启动、入组、日常监查、数据清理和中心关闭等各个阶段。
2. 项目管理：CRA协助项目经理制定监查计划，掌握临床试验方案，熟悉临床电子管理系统的填报。
3. 物资和文件管理：负责试验药品、物资、文件的申请和回收清点，确保试验文件的妥善保管和归档。
4. 沟通与协调：协调研究者、研究机构、CRC、申办方等，管理临床试验事务。与研究中心的研究者进行沟通，处理数据答疑等事宜，并跟进试验过程中不良事件和严重不良事件的处理。

1. Monitoring and Data Management:The CRA is responsible for comprehensive monitoring of clinical trial activities in accordance with the study protocol and Good Clinical Practice (GCP) guidelines, ensuring authenticity, accuracy, and completeness of data. Responsibilities span all trial stages, including site selection, initiation, ethics review, activation, subject enrollment, routine monitoring, data cleaning, and site closure.
2. Project Management:Assist the Project Manager in developing monitoring plans, gain thorough understanding of the clinical trial protocol, and become proficient in using electronic clinical management systems for data entry and reporting.
3. Supplies and Documentation Management:Manage the requisition, retrieval, and inventory of investigational products, trial supplies, and documents. Ensure proper maintenance and archiving of all trial-related documentation.
4. Communication and Coordination:Serve as a liaison among investigators, research institutions, CRCs, and sponsors to facilitate clinical trial operations. Communicate with site investigators to address data queries and follow up on the management of adverse events (AEs) and serious adverse events (SAEs) throughout the trial process.

1. 教育背景：需要具备医学、药学、护理学、预防医学、公共卫生、医学类或相关生命科学专业背景，应届毕业生或无课程任务在校生。
2. 经验：了解GCP及临床试验行业者优先。
3. 技能和能力：英语水平良好，熟悉办公软件使用，具备良好的组织协调、沟通谈判能力，能够积极、主动地汇报工作进展，并解决突发问题。
4. 职业素养：能承受工作压力，具备异地出差的适应能力。

1. Education:Degree in Medicine, Pharmacy, Nursing, Preventive Medicine, Public Health, or related life sciences fields. Fresh graduates or current students without course conflicts are welcome to apply.
2. Experience:Prior knowledge of GCP and the clinical trial industry is preferred.
3. Skills and Abilities:Strong command of English; proficiency in office software applications; excellent organizational, coordination, communication, and negotiation skills. Ability to proactively report work progress and resolve unexpected issues.
4. Professional Attributes:Capable of working under pressure and adaptable to business travel as required.