临床协调员CRC（赣南一附院）

岗位职责 / Job Responsibilities 1. 数据与信息管理 / Data and Information Management 负责受试者数据库的建立与日常管理，确保信息录入的准确性与及时性； Establish and manage the subject database on a daily basis, ensuring the accuracy and timeliness of data entry. 2. 受试者随访管理 / Subject Follow-up Management 负责受试者日常随访的预约、提醒及行程安排，保障访视按计划顺利进行； Handle the scheduling, reminders, and arrangements for subjects' routine follow-up visits, ensuring visits proceed smoothly as planned. 3. 研究者文件夹（ISF）管理 / Investigator Site File (ISF) Management 负责研究者文件夹的建立、日常维护与更新，确保试验文档的完整性与合规性； Establish, maintain, and update the Investigator Site File (ISF) on a daily basis, ensuring the completeness and compliance of trial documents. 4. 物资与药品管理 / Supplies and IP Management 负责研究文件、试验药品及相关物品的接收、发放、保存、清点和归还，并做好相关记录与台账管理； Manage the receiving, dispensing, storage, inventory, and return of study documents, Investigational Products (IP), and related supplies, maintaining accurate records and logs. 5. 数据录入与核对 / Data Entry and Verification 协助研究者完成病例报告表（CRF）的数据录入，并进行源数据核对，确保数据的真实、准确与可溯源； Assist investigators with the data entry of Case Report Forms (CRF) and conduct source data verification (SDV) to ensure data authenticity, accuracy, and traceability. 6. 多方沟通协调 / Multi-party Communication and Coordination 作为沟通桥梁，高效协调临床监查员（CRA）与研究者之间的沟通，协助准备监查访视文档，推进项目顺利开展。 Act as a communication bridge to effectively coordinate between Clinical Research Associates (CRAs) and investigators, assist in preparing for monitoring visit documents, and facilitate the smooth progress of the project. 任职要求 / Qualifications 有1~3年 CRC或临床试验相关工作经验者优先； 1-3 years of working experience as a CRC or in clinical trials is preferred. 熟悉GCP法规及临床试验基本流程； Familiarity with GCP regulations and basic clinical trial processes.