诺和诺德（中国）制药有限公司招聘CRA

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Main Tasks:

1. LTM and/or Monitor for CDP/local trials conducted in CRO

Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study. from trial set up to end of trial at assigned trial site(s) as required, including monitoring, source data verification and liaising closely with local trial manager.

Assisting with preparation of protocols and other necessary documents required for trial approval by HA.that meets regulatory requirements.

Preparing protocols and other necessary documents required for trial approval by EC and getting EC approval on time.

and monitoring ethics committee and health authority applications to obtain rapid approval of clinical trials.

Submitting progress or status reports to local trial manager and/or internal departments or management as requiredMonitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly..

Coordinating and giving input toion all end of trial activities including query resolution, site closure and collection of documentation required for clinical trial reports after trail end.

Ensuring but not limited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.

Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOPto health authorities per requirements

Monitoring ongoing project costs and taking corrective action where necessary

Giving input to the integrated clinical/statistical trial reports

Maintaining, updating and archiving allof clinical trial master files on time.

Maintaining up to date knowledge of diabetes treatment, company products, and clinical trial conduction..

Any other responsibilities and duties which may be required from time to time.

II. Clinical Quality Assurance

Help to improve CQA function in overall trial and system quality assurance by performing or giving input in

Co-monitoring

Trial site compliance check

TMF review

System compliance check

Identifying trends of deficiencies from above initiatives and formulate necessary training as preventive action.

Maintaining up to date knowledge by attending relevant quality training.

Education and Experience Requirements of the Position:

1. Bachelor’s degree of Medical science and the relevant working experience.

2. Fluency English on both written & verbal.

人格的完善是本，财富的确立是末。 ;www.yingjiesheng.com@;