Job summary
The
Quality Assurance (QA) Team is recruiting!
The
Research and Innovation Department is looking for an Assistant Clinical
Quality Assurance Manager to join the QA Team. It is a full time post (1.0
WTE), with a temporary contract until 26th June 2026, to cover a period of
maternity leave. This post will be primarily based at St. James University
Hospital, with occasional travel to other LTHT sites required. Although a
nursing background is not essential for the role, the post would be
particularly suited to an experienced Nurse, due to the requirement for
knowledge of clinical governance.
The
Assistant Clinical QA Manager supports the Research & Innovation CSU by
leading on clinical effectiveness and maintaining high standards of quality
assurance across clinical research. Reporting to the QA Manager, the
postholder is responsible for implementing, monitoring, and improving quality
systems in line with Good Clinical Practice (GCP), UK regulatory frameworks,
and Trust governance policies.
If
you are interested in the post, we would like to encourage you to contact the
recruiting manager for an informal discussion.
Main duties of the job
What
the candidate will do:
We
are looking to recruit a proactive and self-motivated individual with a keen
interest in research to work within the QA Team.
Key
responsibilities include developing and reviewing policies, overseeing
internal audits, managing clinical governance portfolios, and ensuring
compliance with statutory and national standards. The role involves analysing
risks, implementing performance indicators, and producing assurance reports
for senior committees. The postholder will also support continuous quality
improvement by promoting best practice, sharing lessons learned, and
contributing to service evaluation and improvement.
The
role requires close collaboration with research teams, clinical staff,
management, and external partners to ensure robust governance across all
R&I services. Additional duties include joint administration of the
document management system (Q-Pulse), training staff, supporting audit
readiness, and deputising for the QA Manager. This role is central to
safeguarding patient safety, ensuring research integrity, and maintaining the
Trusts reputation as a leader in clinical research.
About us
Research
is at the heart of our Trust. Leeds Teaching Hospitals is involved in
research at all levels, developing and trialling new treatments for patients.
We believe that being involved in cutting-edge research helps us provide
better care to our patients.
Over
the next 5 years, we aim to be the best Trust to deliver high-quality
clinical research and to champion research amongst our staff. We also aim to
support and grow our world-class clinical infrastructure and assets for
research and innovation.
We
have a very proactive Research Academy. It offers an extensive programme of
education and training tailored to meet the needs of individuals, teams
involved in clinical research delivery in Health and Social Care.
Our
five Trust values are part of what make us different. They have been
developed by our staff. They are:
-
Patient-centred
-
Collaborative
-
Fair
-
Accountable
-
Empowered
Leeds
Teaching Hospitals is committed to our process of redeploying 'at risk'
members of our existing workforce to new roles. As such, all our job adverts
are subject to this policy and we reserve the right to close, delay or remove
adverts while this process is completed. If you do experience a delay in the
shortlisting stage of the recruitment cycle, please bear with us while this
process is completed, and contact the named contact if you have any
questions.
Job description
Job responsibilities
To
take the lead on Clinical Effectiveness in Research & Innovation by
developing
and maintaining policies and providing a source of advice and
expertise
for staff at all levels. To monitor and review all aspects of risk
management
and ensure compliance with the relevant organisational standards
and
UK regulatory and governance requirements as per Trust polices.
To
develop and implement robust assurance reporting systems and provide
assurance
reports for reporting at relevant Trust committees.
To
implement performance indicators for Quality and implement processes for
their
collation and reporting through directorate performance reviews and the
relevant
reports.
To
contribute to continuous quality improvement across research &
innovation,
by
implementing and influencing the development and application of the Trusts
Quality
Improvement Strategy.
To
maintain the Research & Innovation Directorate Clinical Governance
Portfolio,
working
with Lead Nurse Team and Research Managers to promote good
governance
and provision of assurance against the clinical governance portfolio
requirements
Job description
Job responsibilities
To
take the lead on Clinical Effectiveness in Research & Innovation by
developing
and maintaining policies and providing a source of advice and
expertise
for staff at all levels. To monitor and review all aspects of risk
management
and ensure compliance with the relevant organisational standards
and
UK regulatory and governance requirements as per Trust polices.
To
develop and implement robust assurance reporting systems and provide
assurance
reports for reporting at relevant Trust committees.
To
implement performance indicators for Quality and implement processes for
their
collation and reporting through directorate performance reviews and the
relevant
reports.
To
contribute to continuous quality improvement across research &
innovation,
by
implementing and influencing the development and application of the Trusts
Quality
Improvement Strategy.
To
maintain the Research & Innovation Directorate Clinical Governance
Portfolio,
working
with Lead Nurse Team and Research Managers to promote good
governance
and provision of assurance against the clinical governance portfolio
requirements
Person Specification
Skills & behaviours
Essential
- Proven ability to motivate and train a large work force with people from different backgrounds and abilities and work as a member of a team.
- The ability to manage and work flexibly including on call rota for emergency freezer management.
- Be able to prioritise work efficiently.
- Be able to manage change within a large complex organisation
- Professional approach to all aspects of work, in particular subscribing to and the adoption of total quality management, ethical codes of conduct and Trust codes of conduct.
- High level of computer literacy with experience of using core Microsoft Office programmes
- Excellent communication skills, particularly the ability to deal with staff throughout the organisation and an ability to explain contentious issues to staff.
- Experiences of carrying out quality audits, identifying non compliances and applying corrective actions to shortfalls
- Experience of designing and delivering training
- Experience in SOP writing and presenting complex information clearly
- Ability to demonstrate initiative and think strategically and creatively to resolve problems
- Have a track record in effective project management
- Be able to work with tact and sensitivity but also with persistence to achieve results within tight time frames
- Excellent interpersonal skills with an ability to work co-operatively with others at all levels and to achieve results through other people without necessarily using formal line management aut
- Demonstrate tact and diplomacy as well as the ability to be assertive when required
Desirable
- Experience of presenting using Power Point
- Experience of using electronic document management systems such as Q-Pulse
- Evidence of effective negotiation and facilitation skills
- Manage organisational change within an overall strategic plan
Qualifications
Essential
- Educated to degree level in a life science or health related subject or be able to demonstrate relevant experience commensurate with this post.
- Significant experience of working in a regulatory environment
- Demonstrate evidence of continuing professional development and training
Desirable
- Certificate in Quality Assurance.
- Experience in working across the Higher Education/ NHS interface
- Certificate in Good Clinical Practice (GCP).
- Quality assurance experience at managerial level in a clinical trials or laboratory environment
Experience
Essential
- Knowledge of regulatory and governance environment in the UK and Europe and the impact of regulatory issues on clinical trials
- Evidence of service evaluation and improvement.
- Awareness of Quality agenda, including clinical governance, clinical effectiveness and clinical audit
Desirable
- Knowledge of the Human Tissue Act
- Current working knowledge of the General Data Protection Regulation, GCP, GCP for laboratories, Research Governance, other key regulatory areas and ethical frameworks
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post
Person Specification
Skills & behaviours
Essential
- Proven ability to motivate and train a large work force with people from different backgrounds and abilities and work as a member of a team.
- The ability to manage and work flexibly including on call rota for emergency freezer management.
- Be able to prioritise work efficiently.
- Be able to manage change within a large complex organisation
- Professional approach to all aspects of work, in particular subscribing to and the adoption of total quality management, ethical codes of conduct and Trust codes of conduct.
- High level of computer literacy with experience of using core Microsoft Office programmes
- Excellent communication skills, particularly the ability to deal with staff throughout the organisation and an ability to explain contentious issues to staff.
- Experiences of carrying out quality audits, identifying non compliances and applying corrective actions to shortfalls
- Experience of designing and delivering training
- Experience in SOP writing and presenting complex information clearly
- Ability to demonstrate initiative and think strategically and creatively to resolve problems
- Have a track record in effective project management
- Be able to work with tact and sensitivity but also with persistence to achieve results within tight time frames
- Excellent interpersonal skills with an ability to work co-operatively with others at all levels and to achieve results through other people without necessarily using formal line management aut
- Demonstrate tact and diplomacy as well as the ability to be assertive when required
Desirable
- Experience of presenting using Power Point
- Experience of using electronic document management systems such as Q-Pulse
- Evidence of effective negotiation and facilitation skills
- Manage organisational change within an overall strategic plan
Qualifications
Essential
- Educated to degree level in a life science or health related subject or be able to demonstrate relevant experience commensurate with this post.
- Significant experience of working in a regulatory environment
- Demonstrate evidence of continuing professional development and training
Desirable
- Certificate in Quality Assurance.
- Experience in working across the Higher Education/ NHS interface
- Certificate in Good Clinical Practice (GCP).
- Quality assurance experience at managerial level in a clinical trials or laboratory environment
Experience
Essential
- Knowledge of regulatory and governance environment in the UK and Europe and the impact of regulatory issues on clinical trials
- Evidence of service evaluation and improvement.
- Awareness of Quality agenda, including clinical governance, clinical effectiveness and clinical audit
Desirable
- Knowledge of the Human Tissue Act
- Current working knowledge of the General Data Protection Regulation, GCP, GCP for laboratories, Research Governance, other key regulatory areas and ethical frameworks
Additional Requirements
Essential
- Able to fulfil Occupational Health requirements for the post
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.
