Assistant Quality Assurance Manager
*this post is now closed*
Location: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Faculty / Function: Administrative & Clerical
Salary: £38,890 – £44,503 per annum
Closing Date: 26/02/2021
Contract Type: Fixed term (12 months from date of appointment)
Contracted Hours per week: Full Time
A challenging and exciting opportunity has arisen at one of the leading NHS Hospitals Trusts in the Research & Development department (Newcastle Joint Research Office “NJRO”). The post holder will play a key role within the NJRO team – a joint venture between Newcastle Hospitals and Newcastle University, established to support high quality research at a local and national level.
Reporting to the Quality Assurance Manager (Good Clinical Practice “GCP” Lead) and Quality Assurance and Development Manager (Human Tissue Governance Lead), the post holder will be responsible for supporting the development, implementation and maintenance of the quality management system for Trust human tissue holdings under the Human Tissue Act (2004). In addition they will facilitate the integration of GCP and Good Clinical Laboratory Practice (GCLP) into the Trust and University laboratories supporting clinical research.
The post holder will work closely with the NJRO QA Management Team to ensure the effective handling and management of human biological samples, as part of Clinical Trials and biobanks, is conducted to the highest standard in accordance with all Regulations and relevant SOPs.
Working closely with the Regulatory Compliance Team and broader NJRO team, other specialist Quality Managers, delegated Clinical Trials Unit, the Clinical Team and Principle Investigators, they will provide expert advice on all aspects of HTA/GCP/GCLP quality assurance and research related regulations. Conduct of audits will be a key aspect to the role including site visits to other organisations outside the Trust, when required. Preparation, approval and implementation of quality assurance documentation with delivery of associated training are also required.
A Masters Level qualification, or equivalent qualification or experience, is required. Practical and/or theoretical experience of quality assurance and governance is also sought, with a good understanding of the GCP/HTA regulations and research ethics. The post holder will also need the ability to work independently and manage their own time while still remaining an active team member. An outstanding attention to detail along with the ability to analyse, interpret and compare a range of complex information is essential for this post.
We would welcome applications from staff considering a secondment from their current post.