北京招聘

The key responsibilities for the role will include:

· Provision of clinical research compliance advice to George Clinical colleagues

· Conducting quality management review activities including (but not limited to) process reviews, vendor assessments, essential document and project file reviews and compliance/co-monitoring visits to study sites for the US as required

· Verifying the implementation of corrective and preventive actions identified during conduct of internal and external audits, compliance activities and other performance monitoring activities

· Monitoring and delivering continuous improvements to all George Clinical processes under guidance from the global head of clinical research compliance

· Training staff in appropriate procedures, processes and systems where required and in alignment with global initiatives

· Implementation of the training programme and framework including delivery and some development of training modules as required.

· Conducting audits, depending on the experience of the successful candidate and subject to completion of our internal auditor qualification process,

The ideal candidate will possess:

· Tertiary qualifications in a health-related field, or relevant equivalent work experience

· Strong knowledge of ICH-GCP guidelines global and US ethical and regulatory requirements for clinical research

· Knowledge and experience with the conduct of clinical research compliance activities, site and process audits or reviews to meet GCP standards

· At least 5 years’ experience in site monitoring in a CRO or Pharmaceutical or Device company with additional clinical operations/project management experience including phase II-IV global studies

· Ability to coach and mentor staff in relation to non-compliance and performance issues.

· Experience and/or qualifications in the training of clinical research staff preferred

· Technological proficiency including Microsoft Office packages

· Ability to see the big picture, yet still focus on detail and quality of work.

We are searching for individuals who are results oriented and able to handle rapidly changing priorities in a fast moving environment. You must be willing to extend yourself, take on new challenges with a ‘can do’ attitude and work with locally and regionally based team members.

Our preferred candidates will be based in Beijing.

On offer is a competitive compensation and benefits package, flexible working options and sound learning and development opportunities.

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The George Institute China is a medical research institute, and a wholly-owned foreign enterprise, that was established as an affiliated partner with Peking University Health Science Centre in March 2007, whose registered name is Beijing George Medical Research Co. Ltd. The aim of the Institute is to promote high quality medical research through the conduct of randomised controlled trials and epidemiological studies with various government and non-government partners for the purpose of providing evidence-based approaches to improve the health of Chinese people.
George Clinical is the clinical research delivery arm of the George Institute and manages phase I to phase IV clinical studies for both commercial and medical research organisations. George Clinical is recognized as a leading Clinical Research Organisation (CRO) bringing together medical and scientific expertise in the clinical trials area. George Clinical China is a wholly owned foreign enterprise and trades under the name George (Beijing) Clinical Research Co. Ltd.