崗位要求：

1、臨床醫(yī)學(xué)、臨床藥學(xué)、預(yù)防醫(yī)學(xué)、藥學(xué)、護(hù)理學(xué)等相關(guān)專業(yè)本科及以上學(xué)歷；

2、CET6，讀寫流利；

3、有志于在臨床試驗(yàn)行業(yè)發(fā)展，工作表現(xiàn)優(yōu)秀有留用機(jī)會(huì)；

4、此職位面向2019年畢業(yè)生，希望每周實(shí)習(xí)3天以上，持續(xù)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