
此信息由前程无忧(51JOB)审核并发布(查看原发布网址),应届生求职网转载该信息只是出于传递更多就业招聘信息,促进大学生就业的目的。如您对此转载信息有疑义,请与原信息发布者前程无忧(51JOB)核实,并请同时联系本站处理该转载信息。
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