Job summary
We are delighted to offer a challenging and rewarding opportunity to join two leading NHS Hospital Trusts at the forefront of clinical research. This unique role spans Gateshead Health NHS Foundation Trust and The Newcastle upon Tyne Hospitals NHS Foundation Trust, with the post holder dividing their time equally between the two organisations. Within Newcastle there will be a particular focus on supporting the Newcastle Clinical Research Facility (NCRF).
As a key member of the Research & Development teams, you will play a vital role in supporting the development, implementation, and maintenance of robust Quality Management Systems to meet regulatory and accreditation standards.
- Interview Date Friday 17 October 2025
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy
NO AGENCIES PLEASE
Main duties of the job
Working closely with the NCRF Quality Assurance Manager and both Regulatory Compliance Teams, you will ensure that the sponsorship and delivery of clinical trials across both Trusts are conducted to the highest standards of Good Clinical Practice (GCP) and in line with all relevant regulations and guidance.
This is a varied and influential role involving:
- Providing expert advice on all aspects of research quality assurance and regulatory compliance
- Leading and conducting audits, including site visits to external organisations
- Preparing, approving, and implementing quality assurance documentation
- Delivering training to embed best practice across teams
You will hold a Master's degree (or equivalent qualification/experience) and bring strong knowledge of the clinical trial process, GCP, and hands-on experience of quality assurance across diverse research settings. Excellent communication and collaboration skills are essential, as you will work closely with multidisciplinary teams to ensure high-quality, compliant research.
This role offers a unique opportunity to contribute to nationally recognised research excellence, supporting the development and delivery of safe, innovative, and high-quality clinical trials that make a real difference to patients.
About us
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:
o Freeman Hospitalo Royal Victoria Infirmary (RVI)o Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)o Newcastle Dental Hospitalo Newcastle Fertility Centreo Northern Centre for Cancer Care, North Cumbriao Northern Genetics Serviceo Cramlington Manor Walks
These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust
Job description
Job responsibilities
- The post holder has overall responsibility for directing quality operations across the components of the NIHR Newcastle CRF that includes: the RVI CRF based in the Leazes Wing of the RVI; the Clinical Ageing Research Unit (CARU) at the Campus for Ageing and Vitality; and the Dental CRF in the Newcastle Dental School.
- The post holder will play a key role in the formulation and delivering our quality strategy that assures the wellbeing of research participants and the integrity of trial data, in compliance with current legislation and regulatory requirements.
- The primary purpose of the post is to establish the processes and operational procedures that will generate the platform for future application to the MHRA Phase I Accreditation Scheme.
- The post holder will be responsible for promoting a culture of continuous quality improvement by providing informed guidance and training to staff working within the NIHR Newcastle CRF and involved with its outreach activity.
Job description
Job responsibilities
- The post holder has overall responsibility for directing quality operations across the components of the NIHR Newcastle CRF that includes: the RVI CRF based in the Leazes Wing of the RVI; the Clinical Ageing Research Unit (CARU) at the Campus for Ageing and Vitality; and the Dental CRF in the Newcastle Dental School.
- The post holder will play a key role in the formulation and delivering our quality strategy that assures the wellbeing of research participants and the integrity of trial data, in compliance with current legislation and regulatory requirements.
- The primary purpose of the post is to establish the processes and operational procedures that will generate the platform for future application to the MHRA Phase I Accreditation Scheme.
- The post holder will be responsible for promoting a culture of continuous quality improvement by providing informed guidance and training to staff working within the NIHR Newcastle CRF and involved with its outreach activity.
Person Specification
Qualifications & Education
Essential
- Masters Level qualification or equivalent qualification or equivalent experience
Knowledge & Experience
Essential
- Sound working knowledge of quality assurance and its implementation in practice
- Working knowledge of regulatory frameworks and legislation governing the conduct of clinical research. This includes but is not restricted to understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Human Tissue Act (2004) regulations and research ethics
- Experience of and/or participation in the audit process in a regulatory controlled environment
- Experience of and/or participation in external inspections
- An understanding of the clinical trials process
- Experience of monitoring compliance with quality standards
Desirable
- Knowledge of the MHRA Phase I Accreditation Scheme, with an understanding of the implications for quality systems and how the requirements can be met in hospital-based clinical research units
- Evidence of undertaking, co-ordinating or managing clinical research, and demonstrating experience of working on phase I, II and III clinical trials
- An understanding of NHS Research and Development (R&D and the overarching NHS R&D strategy)
- Experience of conducting audits including site, database, documentation and systems
- Knowledge of legislation and regulations governing the safe handling and delivery of advanced therapies
- Project Management
- Awareness of a clinical/hospital environment
Skills & Abilities
Essential
- Excellent written and oral communication skills, including presentations
- Excellent interpersonal skills in dealing with a diverse range of staff
- Ability to contribute to a team approach and proven experience of working as part of a multi-disciplinary team
- Excellent time and workload management skills, with the ability to prioritise, plan and work to agreed timescales and to multitask effectively under pressure, maintaining high quality work
Desirable
- Ability to analyse, interpret and compare data
- Well-developed IT skills and the ability to interrogate complex systems and understand concepts relating to the maintenance of electronic data and security
Person Specification
Qualifications & Education
Essential
- Masters Level qualification or equivalent qualification or equivalent experience
Knowledge & Experience
Essential
- Sound working knowledge of quality assurance and its implementation in practice
- Working knowledge of regulatory frameworks and legislation governing the conduct of clinical research. This includes but is not restricted to understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Human Tissue Act (2004) regulations and research ethics
- Experience of and/or participation in the audit process in a regulatory controlled environment
- Experience of and/or participation in external inspections
- An understanding of the clinical trials process
- Experience of monitoring compliance with quality standards
Desirable
- Knowledge of the MHRA Phase I Accreditation Scheme, with an understanding of the implications for quality systems and how the requirements can be met in hospital-based clinical research units
- Evidence of undertaking, co-ordinating or managing clinical research, and demonstrating experience of working on phase I, II and III clinical trials
- An understanding of NHS Research and Development (R&D and the overarching NHS R&D strategy)
- Experience of conducting audits including site, database, documentation and systems
- Knowledge of legislation and regulations governing the safe handling and delivery of advanced therapies
- Project Management
- Awareness of a clinical/hospital environment
Skills & Abilities
Essential
- Excellent written and oral communication skills, including presentations
- Excellent interpersonal skills in dealing with a diverse range of staff
- Ability to contribute to a team approach and proven experience of working as part of a multi-disciplinary team
- Excellent time and workload management skills, with the ability to prioritise, plan and work to agreed timescales and to multitask effectively under pressure, maintaining high quality work
Desirable
- Ability to analyse, interpret and compare data
- Well-developed IT skills and the ability to interrogate complex systems and understand concepts relating to the maintenance of electronic data and security
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to 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) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to 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) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
