Clinical Research Associate

阿斯利康; Hong Kong; On-site; HKD 720,000 - 980,000; Full time

Benefits offered by this job

导师带教，学术知识培训

商业保险

丰富补贴

定期体检

医疗保险及子女医疗保险

零食无限

五险一金

弹性福利

免费午餐

补充商业保险

企业年金

奖金

五险一金商业保险等福利

津贴

培训

保险

通讯补贴

Job summary

阿斯利康在香港招聘临床监查专员，负责确保ICH-GCP与AZ程序文件及本地法规的合规性。将参与Study Delivery Team会议，协助站点筛选、培训研究者及站点人员，并推动站点表现与患者招募进展。

岗位要求具备MC CRA/临床监查经验、良好英语沟通能力及对临床数据流与药物开发流程的深入理解。工作中需与数据管理、QA等团队密切协作，确保研究数据质量及合规性。

Qualifications

• 具备MC CRA/临床监查经验，熟悉监查任务
• 熟练运用英语进行专业沟通
• 理解临床数据流及研究流程
• 掌握GCP/ICH指南及药物开发过程
• 具备良好计算机操作能力

Responsibilities

• 按照ICH-GCP、AZ程序文件及本地法规要求，获取并维护关键文件
• 参与本地Study Delivery Team会议
• 培训并支持研究者及站点人员
• 在站点执行监查、招募信息及研究站点进展的沟通
• 确认并处理研究相关问题，必要时进行升级
• 更新IMPACT及其他系统中中心数据
• 管理研究用品及药品供应与药品清点
• 进行源数据核查并确保数据质量
• 对不良事件进行及时且准确的报告
• 为审计及监管检查做准备并与QA沟通
• 撰写并提交监查 visit 报告
• 与数据管理协作确保研究数据质量
• 确保符合公司行为准则与相关政策

Skills

临床监查经验

英语能力（良好）

数据流程理解

计算机熟练

Education

生物科学相关学位或等同学历

Job description

Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site.

Actively participate in local Study Delivery Team meetings.

Contribute to the selection of potential investigators.

Train, support and advise Investigators and site staff in study related matters.

Contribute to national Investigators meetings.

Initiate monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.

Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.

Update IMPACT and other systems with data from centres as per required timelines.

Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.

Perform source data verification according to SDV plan.

Ensure accurate and timely reporting of Serious Adverse Events.

Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.

Provide the required monitoring visit reports within required timelines.

Work with data management to ensure quality of the study data.

Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Job Descriptions

Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site.

Actively participate in local Study Delivery Team meetings.

Contribute to the selection of potential investigators.

Train, support and advise Investigators and site staff in study related matters.

Contribute to national Investigators meetings.

Initiate monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.

Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.

Update IMPACT and other systems with data from centres as per required timelines.

Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.

Perform source data verification according to SDV plan.

Ensure data query resolution.

Ensure accurate and timely reporting of Serious Adverse Events.

Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.

Provide the required monitoring visit reports within required timelines.

Work with data management to ensure quality of the study data.

Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Job Qualifications

University degree in biological science or healthcarerelated

field, or equivalent

Experience as a MC CRA/ clinical monitor, performed all

tasks for a CRA position

Understanding of the clinical dataflow

Very good knowledge of the clinical study and drug development processes, GCP/ICH guidelines

Computer proficiency

Very good knowledge of spoken and written English

Job Type

Recruitment Type：Experienced

Work Type：Full-Time

Benefits

• 导师带教，学术知识培训
• 商业保险
• 丰富补贴
• 定期体检
• 医疗保险及子女医疗保险
• 零食无限
• 五险一金
• 弹性福利
• 免费午餐
• 补充商业保险
• 企业年金
• 奖金
• 五险一金商业保险等福利
• 津贴
• 培训
• 保险
• 通讯补贴