Faculty of Medicine and Health
Faculty of Medicine and Health Research Office
Quality Assurance (QA) Monitor
Fixed term for 3 years
The University of Leeds is a leader in the field of clinical trials and has an associated research
portfolio.
We are looking for an enthusiastic individual to lead the monitoring / auditing aspect of the LTHT
and University of Leeds portfolio of clinical trials and their associated quality assurance systems
according to legislation and good clinical practice.
The post will be based at the Quality Assurance Clinical Trials Office, within the Research &
Development Offices of Leeds Teaching Hospitals NHS Trust, providing a designated quality
assurance function working across the University’s Faculty of Medicine and Health’s Research
Office and Leeds Teaching Hospitals NHS Trust’s Department of Research and Innovation.
You will have experience of working in a quality-assured clinical research environment, including
experience of Phase II / III trials, a degree in life science or a health-related subject is desirable.
You should also have a current working knowledge of applicable legal and ethical frameworks, in
particular the Research Governance Framework for Health and Social Care, and Good Clinical
Practice (GCP) issues relevant to the conduct and management of clinical research in the NHS.
Attention to detail, organisational, interpersonal and communication skills (including written and
presentational skills) plus an understanding of key issues pertaining to clinical research are
essential.
The University of Leeds is committed to providing equal opportunities for all. The
university is a charter member of Athena SWAN and holds the Bronze award. We will be
happy to consider job share applications and are committed to flexible working for all our
employees.
University Grade 6 (£25,513 – £30,434 p.a.) depending on qualifications and experience
Informal enquiries to Clare Skinner, Faculty Head of Research & Innovation Support, email;
C.E.Skinner@leeds.ac.uk, tel. + 44 (0) 113 343 4897
If you have any specific enquiries about your online application please contact Emma
Heatley, email; e.heatley@leeds.ac.uk, tel. + 44 (0) 113 343 4062
Job Ref: MHFAC1017
Closing Date: 6 September 2015
It is anticipated that interviews will be held on 16 September 2015
Background
This post is joint funded by the University of Leeds and the Leeds Teaching Hospital Trust to plead
on the monitoring and audit aspects of compliance to The Medicines for Human Use (Clinical
Trials) Regulations 2004 (S.I. 2004 No. 1031) including related amendments and the Commission
Directive 2005/28/EC on Good Clinical Practice Directive, related to clinical trials across the two
organisations.
The University of Leeds and Leeds Teaching Hospitals NHS Trust have establishing an integrated
research management function for clinical research. For the purpose of research approval, a joint
University/Trust research office has been established to approve clinical research conducted
and/or led by medical and healthcare staff employed by the University of Leeds and the Leeds
Teaching Hospitals NHS Trust. A key function of the joint University/Trust research office is the
assessment of compliance of clinical research with the Research Governance Framework, the
Medicines for Human Use (Clinical Trials) Regulations 2004 for new clinical trials and ongoing
studies in Leeds.
The post holder will be based at the LTHT R & D office providing a designated quality assurance
function across both organizations through the University’s Faculty of Medicine and Health’s
Research Office, the NHS Trust’s Department of Research and Development liaising with the
Clinical Trials Research Unit.
Purpose of the Post
To support the monitoring and auditing of clinical research within the University of Leeds and the
Leeds Teaching Hospital NHS Trust reporting upon compliance The Medicines for Human Use
(Clinical Trials) Regulations 2004 and the EU Clinical Trials Directive (2001/20/EC).
 Provide advice on issues associated with and requirements for The Medicines for Human Use
(Clinical Trials) Amendment Regulations 2006 (S.I. 2006 No. 1928) and the Commission
Directive 2005/28/EC on Good Clinical Practice to the Director of R&I, and Faculty Head of
Research and Innovation Support (FMH) for the University of Leeds.
 To assist in developing an ongoing internal Good Clinical Practice monitoring programme of
Clinical Trials Involving Medicinal Products (CTIMPs) in the University of Leeds (UoL) or the
LTHT
 Provide advice to individual researchers on issues relating to protocol development and trial
management of CTIMPs being sponsored by the UOL / LTHT.
 To work with academic staff, local business managers, faculty and Trust senior management
teams and local clinical trial coordinators to improve the delivery of clinical research activity,
including reviewing and advising on standard operating procedures (SOP) to ensure they meet
the legislative framework for clinical research activity and providing written reports and post
audit feedback meetings to highlight areas of strength and weakness and share best practice
across the University and the Leeds Teaching Hospital Trust
 Assist in updating of the database for recording of information relating to CTIMPs and of the QA
monitoring processes.
 Assist in the performance of Good Clinical Practice Audits and writing of audit reports.
 Development and dissemination of training materials to researchers to support the sponsorship
acceptance process and quality assurance systems.
 Advise and report upon compliance with legislation and good clinical practice guidelines related
to clinical research.
 Advise the QA manager and the relevant senior management teams across the Faculty and the
LTHT on the set up and monitoring of clinical research across the two organisations. They
would be expected to act as an expert in the field making independent decisions and
recognising areas of risk within a trial both at set up and monitoring.
 Provide support in the review of hosted CTIMPs within the UoL and LTHT
 Maintain an up-to-date understanding and working knowledge of MRC GCP guidelines, ICH
GCP guidelines, Research Governance Framework, Data Protection Act (1998) and the
Medicines for Human Use (Clinical Trials) Regulations 2004
 Maintain an up-to-date understanding of changing legislation associated with GCP and quality
assurance in clinical research.
 Act as a resource to external collaborators on GCP guidelines, Research Governance, Data
Protection Act (1998) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
 Deliver training on GCP and regulatory frameworks for clinical trials to healthcare professionals
and clinical trials staff for example through local and national cancer research network study
days.
 Deliver a monitoring service to the Faculty of Medicine and LTHT, setting up the audit timetable
based on their own risk assessment and be responsible for ensuring the monitoring service is
'fit for purpose' measured against internal and external standards (e.g. MHRA - Medicines and
Healthcare products Regulatory Agency)
Relationships
The post-holder will be responsible to the Quality Assurance Manager and accountable to the
Faculty Head of Research Support. They will work closely with members of the Leeds Cluster, the
Faculty of Medicine and Health Research office, central Research Support and Trust R&D staff
University Values
All staff will be expected to operate in line with the university’s values and standards, which work
as an integral part of our strategy and set out the principles of how we work together. More
information
about
the
university’s
strategy
and
values
is
available
at
http://www.leeds.ac.uk/comms/strategy/.
Person Specification
Essential

Educated to degree level in a scientific subject (or equivalent qualification / experience) or
experience of working in a quality assured clinical research environment

Experience of Research Governance

Understanding of key implications of Medicines for Human Use (Clinical Trials) Regulations
2004 on Clinical Trials

Current working knowledge of Data Protection Act (1998), GCP, Research Governance and
ethical frameworks

Effective team working skills

Evidence of effective negotiation and facilitation skills

Effective interpersonal and communication skills (including written and presentational)

Evidence of effective organisational skills

Attention to detail

Experience in report writing

Ability to demonstrate initiative and flexibility
Desirable

Experience of dealing with academics and health-care professionals at all levels

Experience in audit

A degree in a life science or health-related subject
Faculty Information
With more than 6,000 students, 1,600 staff and annual research income of £50m, the Faculty of
Medicine and Health at Leeds is bigger than some universities. Leeds has one of the largest
medical and bioscience research bases in the UK, and is an acknowledged world leader in cancer,
cardiovascular, psychiatric, genetic, musculo-skeletal and health services research. Treatments
developed in Leeds are transforming the lives of people around the world living with conditions
such as HIV, TB, diabetes and malaria.
Additional Information
Terms and Conditions
Details of the terms and conditions of employment for all staff at the university, including
information on pensions and benefits, are available on the Human Resources web pages
accessible via the links on the right hand side, or at http://hr.leeds.ac.uk/policies
University Teaching and Research Award
The Senate of the University has agreed that all newly appointed staff with a contract of 0.5 FTE
and above who have a teaching/ research role and are deemed new to teaching or research in
Higher Education should be required to complete successfully all of the requirements of the
University of Leeds Teaching and Research or an appropriate alternative. Whether or not this
applies to you will be decided as part of the appointment procedure at interview.
Further details of the ULTRA are available at http://www.sddu.leeds.ac.uk/sddu-ultra.html
Staff with contracts of less than 0.5 FTE may take the ULTRA provided that they have a broad
enough range of teaching, research and assessment to complete the requirements of the
Programme: this will be decided in conjunction with the School and the course providers.
Disclosure and Barring Service checks
A Disclosure and Barring Service (DBS) Check is not required for this position. However,
applicants who have unspent convictions must indicate this in the ‘other personal details’ section
of the application form and send details to the Recruitment Officer
Disabled Applicants
The post is located in the Quality Assurance Clinical Trials Office, within the Research and
development Offices of the Leeds Teaching Hospitals NHS Trust. Disabled applicants wishing to
review access to the building are invited to contact the department direct. Additional information
may be sought from the Recruitment Officer, email disclosure@leeds.ac.uk or tel + 44 (0)113 343
1723.
Disabled applicants are not obliged to inform employers of their disability but will still be covered
by the Equality Act once their disability becomes known.
Further information for applicants with disabilities, impairments or health conditions is
available in the applicant guidance.