西安招聘

职位描述：
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 举报 分享

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