武汉-临床监查员 II (MJ001036)社

面议

武汉市本科及以上1年及以上

发布时间：2024-08-13

职位描述

Primary Responsibilities:
 Perform site selection (if applicable), initiation, monitoring and close-out
visits in accordance with contracted scope of work, SOPs (and / or the
Sponsor’s SOPs as appropriate) and the ICH GCP and associated regulations.
May perform co-monitoring visits and other types of site visits as needed.
 Support development of project subject recruitment plan on a per site basis.
Work with sites to adapt, drive and track subject recruitment plan to meet
project recruitment target.
 Administer protocol and related study training to assigned sites and establish
regular lines of communication with sites, ensure that study milestones for
sites responsible are met as planned with high quality (i.e., study startup,
recruitment, database lock, closeout, etc.)
 Create and maintain appropriate documentation regarding site management,
monitoring visit activities by submitting regular visit reports and/or other
required study documentation.
 Evaluate the quality and integrity of study site practices related to the proper
conduct of the protocol and adherence to applicable regulations. Take
corrective action and preventative actions to mitigate the risk. Escalate quality
issues as appropriate.
 Manage the daily progress of assigned studies by tracking regulatory
submissions and approvals, recruitment and enrollment, case report form
(CRF) completion and submission, Ethics Committee documents submissions
and approvals, study drug management, document filing, site payments, data
query generation and resolution. May support start-up phase and additional
site-self assessment requirements.
 Collaborate and liaise with study team members for other project execution
support as appropriate.
 Performs additional task as assigned by line manager.
 May be assigned as the mentor of less experienced CRAs
 Other activities/tasks assigned by supervisors.

其他要求

招聘人数：1人
职能类别：

公司介绍

昆翎（ClinChoice）是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有1800多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。

高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为，“随着创新疗法在全球的增长，CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力，将为昆翎的发展开启新的篇章。