Syneos CRA (I/II)临床监查员(限时高额入职奖金）

职位来源于智联招聘。

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：

杭州市拱墅区浙江经贸大楼B座5楼

上海市徐汇区古美路漕河泾

北京市朝阳区中关村科技园电子城西区望京

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

• 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.
• 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.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:
• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• The SMA II may be requested to train junior staff
• Identify and communicate out of scope activities to Lead CRA/Project Manager
• 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

• Bachelor’s degree and or above degree with major in medicine/healthcare/life science related
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• 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。

以担保或任何理由索要财物，扣押证照，均涉嫌违法。