Clinical Quality Support and Training Specialist
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职位描述/要求：
Responsibilities:
·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
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. 联系方式：
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