长沙招聘

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

泰格医药是行业领先的一体化生物医药研发服务平台，为全球制药和医疗器械行业提供跨越全周期的临床研究创新解决方案。通过全面的服务体系和***的质量标准，我们助力生物医药产业提升研发效率、降低研发风险，确保研究项目高质量交付，加速医药产品市场化进程，履行对行业和患者的承诺。同时，我们也通过覆盖各领域的80多家子公司，打造赋能全产业链的创新生态，推动医疗产业创新和发展。作为全球化的研发平台，泰格医药在全球布局170多个办事处和研发基地，拥有超过8600人的专业团队，覆盖5大洲的51个国家，致力于解决最具挑战的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。