Position Title

Administrative Regulatory Coordinator 临床研究助理

Summary

Provides administrative and specialized support for the clinical research applications and regulatory coordination of research studies.

为临床研究项目申请和协调工作提供行政和专业支持。

Essential Job Function

？ Assist in the coordination and facilitation of clinical research office standing meetings in distribution of meeting agenda, room reservations, meeting minutes drafting, follow-up communications and all other meeting preparations.

为临床研究部例会提供行政支持：分发会议议程、预定会议室、撰写会议纪要、会后跟踪及其他会议组织工作。

？ Establish a system that manages and maintains administrative and regulatory documents submitted to and distributed from the clinical research office.

建立并维护文件管理体系，包括临床研究部收到和发出的管理类文件及项目文件。

？ Assist study Principal Investigator (PI) in preparing and submitting protocols/amendments/continuing review and relevant supporting documents to the IRB for review and approval.

协助主要研究者准备及向伦理委员会提交研究方案、修正案、跟踪审查及相关支持文件。

？ Assist study PIs in communicating with sponsors and the IRB and submitting required IRB correspondence to sponsors.

协助主要研究者与申办方和伦理委员会进行沟通，以及向申办方提交必要的伦理委员会沟通记录。

？ Assist study PIs/Teams with study start-up and close-out activities to ensure all regulatory documents are completed, collected, and filed.

协助主要研究者/研究团队进行立项和结题工作，确保所有的项目文件妥善完成、汇总和存档。

？ Ensure the study delegation of authority logs, training logs are completed, updated, and filed.

确保研究授权委托记录和培训记录的完整性，并及时更新和存档。

？ Maintain the confidentiality of documents and ensure all documents are well organized for internal or external audits/inspections.

维护文件的保密性，确保所有文件管理有序，便于内外稽查/检查时查阅。

？ Other duties as assigned

上级交派的其他任务

Supervision

Received: Clinical Research Program Manager

Given: None

Education

Bachelor degree in health-related fields, healthcare administration or related scientific field

本科学历，医药专业、卫生管理或其他相关专业。

Experience

Minimum of 2 years of experience in area of clinical research study obtained from nursing, data gathering or other related experience.

至少2年临床研究相关的工作经验，如护理、数据收集等。

Certification

? GCP Certification preferred

GCP证书持有者优先

Other Requirements

? Excellent organization skills and written and oral communication skills

优秀的组织能力、书面和口头沟通能力

? Fluent in Mandarin Chinese and English

流利的普通话和英文

上班地址：桂平路689号