宜昌招聘

工作职责：

1. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, FOUNTAIN SOPs (and / or the Sponsor’s SOPs as appropriate) and the ICH GCP guidelines. May perform co-monitoring visits and other types of site visits as needed.

按照合同约定的工作范围，方恩SOPs（和/或申办方的SOPs，视情况而定）以及ICH GCP指导原则开展中心筛选（若适用），启动访视、监察查视以及关中心访视。可能按需开展协同监查以及其他类型的中心访视。

2. 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.

支持研究中心制定特异性的受试者招募计划。与研究中心一同调整、推动和跟进项目受试者招募计划以完成项目入组目标。

3. 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.)

对指定的研究中心进行方案及其他研究相关培训并且建立与研究中心的常规沟通，以确保中心按期高质量完成项目里程碑计划（如研究启动、入组、数据锁定、关中心等）。

4. Create and maintain appropriate documentation regarding site management, monitoring visit activities by submitting regular visit reports and/or other required study documentation.

建立并维护中心管理相关文件，进行监察访视活动并递交常规访视报告和/或其他要求的研究文件。

5. 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.

评估研究中心按照研究方案并遵守适当的规范实施研究过程的质量及完整性。采取纠正措施及预防措施降低风险。酌情增强对质量问题的重视。

6. 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.

通过跟进管理当局文件有关文件的递交与批准，招募与入组，病例报告表（CRF）的完成和提交伦理委员会文件的递交和批准，研究药物管理，

文件归档，中心研究费用支付，数据质疑的提出和解答进行项目日常管理。可能要支持研究启动阶段及额外的中心评估要求。

7. Collaborate and liaise with study team members for other project execution support as appropriate.

与研究团队其他成员合作并保持联系，酌情获得项目执行相关的支持。

8. Performs additional tasks as assigned by line manager.

执行直属经理分配的其他工作。

9. May be assigned as the mentor of less experienced CRAs.

可能被分配成为经验不足的CRA的指导者。

10. May be delegated by line manager or project manager to be the backups for people management or project management tasks. Or the CRA lead of a clinical project.

可能被直属经理或项目经理委派成为人员管理或项目管理工作的协助者。或者成为一个临床项目的CRA领导。

1. A College or Bachelor (or above) degree in life sciences, pharmacy nursing or medical, at least 4 years’ experience in clinical trials.

大专或本科及以上学历，生命科学、药学、护理或医学相关专业，4年以上临床试验行业经验。

2. Basic knowledge of ICH GCP and associated regulatory guidelines.

基本的ICH GCP及相关法规知识。

3. Basic English skills in listening, speaking, reading and writing.

基本的英语听、说、读、写能力。

4. Good communication, problem solving and self-management skills.

良好的沟通，解决问题和自我管理能力。

5. Capability to identify issue and solve problems independently, effectively and proactively.

能够独立、高效、主动地发现和解决问题。

6. Ability to manage multi-tasks, and prioritize work with attention to details.

能同时完成多任务的处理，能关注细节并按优先级处理好各项事宜。

7. Proficiency in Microsoft office software (such as Excel, Word, PowerPoint, Outlook and so on).

能熟练使用常见办公系统，例如Excel, Word, PowerPoint, Outlook等。

8. Basic mentoring and training skills.

良好的指导和培训能力.

9. Ability to travel.

能接受出差。 

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。