湖州招聘

Purpose of this job:
 Support clinical trial quality system and ensure clinical trial/study conduction in

accordance with GCP, NN SOP and local regulations.
 Support to clinical staffs training for the GCP, SOP and related clinical research

regulations


Area of responsibilities:
Main Tasks:

Clinical Trial Quality Assurance:

·Familiar with ICH GCP, China GCP and company’s SOPs.
·Conduct GCP/SOP compliance check for local and CDP trials. Maintain and follow up action

plan.
·Work as the coordinator to be involved in CQA audit conducted by HQ and help to complete

action plan.
·Perform co-monitoring activities to ongoing trials.
·Implement Quality Activity Plan (QAP) for clinical trial function every year.
·Involve in global SOP review procedure, and give comments accordingly.
·Comparing with QBIQ SOPs, make gap analysis for local SOPs.
·Draft and update Local SOPs.
·Check QBIQ document list according to SOP matrix regularly.
·Support to SOP training workshop, maintain group training records.
·Support to clinical staffs training for the GCP, SOP and related clinical research

regulations.
·Support to GCP training for external customer, as per required.
Supervision:

None

Main customers:
Internal customers:
All the colleagues in clinical trial function of CRO. The clinical operation colleagues in

headquarters, IOCDC & other affiliates.
External customers:
All the healthcare professionals, officials. Especially the investigators in the clinical

trials.



Education and Experience Requirements of the Position:
1. Bachelor’s degree or above of Medical Science.
2. 2-3 years working experience in clinical trials operation area.
3. Working experience in quality area.
4. Fluency English on both written & verbal

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