工作职责：

This position routine work mainly focus on quality control (QC) for projects of CRO and SMO, CRA and CRC training, other works, such as drafting monthly QC report, training new QC, etc.

1.Quality Control
Execute the internal project QC plan.
Assist conducting the external project QC.
Ensure all the staffs are working under the SOP requirement.
Collaborates with and supports staff to resolve quality and compliance issues.
Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results and current routine quality management work.
Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA) and department management, as required.
2.Training
Maintain the CRA/CRC job skill training courses follow by the requirement of company policy and SOP.
Execute the training course (s) and refresh as needed.
Assist the other department to implement training.
3.Others
Provides training to investigational Site staff on ICH-GCP and local regulations if support is required.
Contributes in the monthly QC report, as applicable.
Contributes to the implementation of systems and tools related to the delivery of clinical operational tasks or SOPs, ICH-GCP requirements.
Supports the study team in the preparation for, conduct of and responses to audits, self•verification, inspection readiness and regulatory inspections.

任职资格：

Technical / skills training
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
Good understanding of the drug development process and related GXP activities.
Good understanding of the skills and knowledge required far the successful delivery of a clinical study, e.g. ICH-GCP, study management, site management, monitoring.
Language ability
CET-4 and above or equivalent fluent English in reading, writing and speaking, candidates good at several foreign languages was desirable.
Computer literacy
Proficient with laptop.
Familiar with Microsoft office software (Word, Excel, Power Point, etc) or equivalent software familiar.
Others
Good presentation and communication skills.
Good ability to learn.
Ability to travel nationally and internationally as required.