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Quality Project Specialist

Job Reference: 918-QA3767

Employer:
NHS Blood and Transplant (NHSBT)
Department:
Statistics and Clinical Studies
Location:
Cambridge
Salary:
£42,414 to £49,969 pa

NHS Blood and Transplant (NHSBT) is a Special Health Authority and an integral part of the NHS. In addition to providing blood components and donated organs to the NHS, NHSBT, in partnership with the Universities of Cambridge, Oxford and Bristol conducts world-class research in the fields of transfusion medicine, organ donation, tissues and stem cells. This includes four National Institute for Health Research (NIHR) Blood and Transplant Research Units:

NHSBT supplies blood components to English hospitals, and procures donated organs for the whole of the UK.  It has a licensed manufacturing facility supplying stem cell products, provides therapeutic apheresis services in various hospitals, has a blood component development laboratory and a tissue services group. The CTU is building research collaborations with each of these functions.

NHSBT is seeking an enthusiastic and dynamic part-time Quality Assurance specialist with extensive Good Clinical Practice knowledge and experience to support the Clinical Trials Unit (CTU) and clinical trial sponsor function of the R&D department.

The NHSBT CTU holds full registration with the UKCRC, and supports the translation of NHSBT’s cutting-edge research into clinical practice, as well as collaborating with researchers to optimise the use of blood components, or improve the quality of organs for donation, for example. Our current portfolio includes a range of studies, from large randomised controlled trials to small first in man studies. We are a national CTU with offices located in Bristol, Cambridge and Oxford. Our trials are funded from a variety of sources, including different NIHR funding streams, charities and NHSBT R&D Committee.

The post holder will be based in NHSBT’s Cambridge centre, located on the renowned Cambridge Biomedical Campus, and will be required to travel regularly to other CTU or NHSBT locations for training or meetings. The post holder will be part of a national team of Quality Specialists who support the organisation in meeting all the necessary regulatory requirements and are committed to the quality of NHSBT products and services, ensuring the finest care for donors and best outcomes for patients. NHSBT uses Q-Pulse as its quality management system, and the post-holder will support the CTU in maintaining quality throughout the management of all its trials by reviewing procedures and trial documents for GCP compliance and consistency, conducting periodic internal audits, leading on change controls and incident investigations and performing external supplier audits as needed.

You will be an experienced GCP professional, able to work on your own initiative, think strategically and drive forward the GCP clinical compliance programme. A knowledge of blood components and/or organ donation is desirable but not essential.  atmosphere. You will provide GCP expertise to the CTU, R&D and QA colleagues. NHSBT offers flexible working and you would be joining a friendly and supportive team.  For further information about this post, including informal visits, please contact Alison Deary, Head of Operations, CTU (Alison.deary@nhsbt.nhs.uk 01223 588088).

The advert will close for applications at midnight on the evening of Sunday 3rd March, Interviews will be held on Monday 25th March, subject to confirmation. 




NHS Blood and Transplant (NHSBT) offers a dynamic and friendly working environment where teamwork is highly valued. Personal development is also considered a priority and is supported through extensive training and development opportunities open to all employees.

Three small words, one big difference - Caring, Expert and Quality.

Together we'll save and improve more lives than ever


Tier 2 Certificate of Sponsorship

Applications from job seekers who require Tier 2 sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. The UK Visas and Immigration department requires employers to complete this test to show that no suitably qualified EEA or EU worker can fill the post. For further information please visit the UK Visas and Immigration website.

From 6 April 2017, Tier 2 skilled worker applicants, applying for entry clearance into the UK, must present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) will also be subject to this requirement.

Guidance can be found here Criminal Records Checks For Overseas Applicants



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