岗位要求：

1、临床医学、临床药学、预防医学、药学、护理学等相关专业本科及以上学历；

2、CET6，读写流利；

3、有志于在临床试验行业发展，工作表现优秀有留用机会；

4、此职位面向2019/2020年年毕业生，希望每周实习3天以上，持续半年以上。

Responsibilities

(1) Monitoring

Monitoring

• Perform pre-study visit to ensure the site has adequate resources for the study.
• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined

in protocol, SOP and ICH-GCP.

• Track study recruitment to ensure recruitment target is achieved in all studies.
• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete

monitoring visit report in a timely manner Coordinating

• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for

start-up and throughout the study.

• Assemble site specific EC submission dossier, and ensure submission to EC.

Training

• Provide ongoing training to site staff with regards to ICH-GCP, study protocol and requirements.
• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol

and requirements.

Documentation

• Collect essential documents at study start-up, during and at study close-down. Maintain and

update these documents in investigator files, trial master files.

• Prepare/Pack for archiving at the end of the study.

(2) Drug Safety

• Ensure safety information is disseminated to all sites according SOP and applicable regulations.
• Report SAE promptly according to SOPs and applicable regulations.

(3) Finance and Administration

• Finalize budget and obtain signed contract from site, prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(4) Study Tools and system

• Update and maintain Study tools/systems in a timely manner.

Qualifications

Bachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)

Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/

procedures

Good working and proactive attitude

Value importance of teamwork

Good command of written and verbal English

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