北京 [切换城市] 北京招聘

临床监查员CRA

艾昆纬医药科技(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2022-06-29
  • 工作地点:南京
  • 工作经验:2年经验
  • 学历要求:本科
  • 职位类别:临床监查员

职位描述

Description RESPONSIBILITIESPerform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. ?Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.Build awareness of features and opportunities of study to site.Collaborate and liaise with study team members for project execution support as appropriate.All responsibilities are essential to job functions unless noted as non-essential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIESGood knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e.,Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesStrong therapeutic and protocol knowledge as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computerStrong written and verbal communication skills including good command of English languageStrong organizational and problem-solving skillsEffective time management skillsAbility to establish and maintain effective working relationships with coworkers, managers and clients任职要求:药物相关监查经验一年以上,扎实的GCP知识和监查技能,良好的沟通与协调能力。

职能类别:临床监查员

公司介绍

IQVIA(纽交所代码:IQV)是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识,智能连接医疗生态的各个环节。IQVIA Connected Intelligence?快速敏锐地为客户提供强大的数据洞察,帮助客户加速创新医疗的临床开发和商业化进程,以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工,足迹遍布100多个国家/地区。

IQVIA拥有多元化的加强型隐私技术和保障手段,能够在保护个人隐私的同时对信息进行管理和分析,帮助医疗利益相关方有效开展精准疗法,获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方,获得对疾病、人类行为和科技进步更深入的理解,共同朝着治愈各类疾病的方向迈进。

联系方式

  • Email:chinacampus@iqvia.com
  • 公司地址:越华路112号珠江国际大厦
  • 电话:13522411136