FSP Top Global Pharma 招聘要求： - 统招本科及以上学历，硕士佳 - 1年及以上CRA经验，熟悉GCP, ICH-GCP以及临床研究相关的法规，有肿瘤项目经验优先，免疫/非肿瘤经验也可考虑 - 良好的沟通能力，应变能力和抗压能力 - 英语读写口语良好，CET-6及以上 工作地点： 广州天河区珠江新城 项目及治疗领域： 负责global II/III期肿瘤项目 公司提供丰厚的薪资福利: 五险一金，补充公积金，生日/节假日礼品券，spotlight积分兑换商品 额外津贴：住房补充，交通，餐饮，采暖（仅适用于中国北方地区）等各种津贴 员工健康：补充商业医疗保险，年度健康体检 长期发展：内部转岗机会，丰富的线上线下培训 专业培训：Clinical Training Institute的专业支持，赛纽仕的CRA培训计划由IAOCR认证并颁发相应证书 Job responsibilities 61 Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. 61 Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. 61 Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements 61 May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 61 Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. 61 Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. 61 For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. 61 May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. 61 Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. 61 Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. 61 Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. 61 For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Qualifications What we’re looking for 61 Bachelor’s degree and or above degree with major in medicine/healthcare/life science related 61 Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements 61 Must demonstrate good computer skills and be able to embrace new technologies 61 Excellent communication, presentation and interpersonal skills 61 Ability to manage required travel of up to 75% on a regular basis Syneos Health赛纽仕医药是一家全面整合生物制药解决方案的公司，旨在帮助客户加快推出新疗法的速度。我们站在产品研发的角度，战略性地融合临床研发、医学事务和商业能力，以及时应对最新市场变化。 想了解更多关于我们如何缩短从实验室到现实生活的距离，请访问官网或订阅我们的播客。
