Download Job Description - Nottingham University Hospitals Research

Job Description
JOB TITLE:
Quality Assurance/GCP Auditor
DIRECTORATE:
Research & Innovation (R&I)/Corporate
PAY BAND:
7
REPORTS TO:
Head of Regulatory Compliance
ACCOUNTABLE TO:
Director of Research
JOB SUMMARY
Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit
of patients as a core component of its corporate vision to be the best acute teaching organisation by
2016. In order to realise this vision, NUH has formed a close research partnership with the University
of Nottingham (UoN), with a common research strategy and an integrated system of research
management and governance. This research partnership has been awarded two prestigious National
Institute for Health Research (NIHR) Biomedical Research Units in Gastrointestinal (including Liver)
Disease, Respiratory Disease and Deafness and Hearing Problems and has been outstandingly
successful in other major NIHR competitions. NUH therefore expects to be at the forefront of
innovation in the prevention, diagnosis and treatment of ill health and in the translation of advances in
basic biomedical research into benefits for patients. NUH also hosts the Mid-Trent Cancer Research
Network and the Medicines for Children Research Network.
NUH sponsors and hosts a comprehensive portfolio of Clinical Trials of Investigational Medicinal
Products (CTIMPs). NUH aims to develop and maintain robust pharmacovigilance and quality
assurance systems in order to ensure patient safety and data quality during the conduct of clinical
trials. The post holder will develop, implement and maintain systems to assure the quality of clinical
research undertaken within NUH in accordance with the prevailing legislative and best practice
requirements, including the Research Governance Framework for Health and Social care 2005, Good
Clinical practice as defined in the Medicines for Human Use (Clinical Trials) Regulations, the Human
Tissue Act and the Mental Capacity Act.
The post holder will play a key role in the co-ordination of working practices and policy implementation
to ensure that NUH is at all times compliant with both internal policies and external regulatory
frameworks. The post holder will also play a key role in preparing for external audits and MHRA
inspection.
In undertaking this role, all employees will be expected to behave at all times in a way that is
consistent with and actively supports the principles listed in the Consultation Document on the
creation of the Nottingham University Hospitals NHS Trust. These are:
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The principles of the NHS, where high quality care is provided on the basis of need rather than
the ability to pay.
The contribution of the local community to the development of our services.
Preserving and developing our reputation as a caring organisation.
Developing services that are designed around the patient.
Working co-operatively with others in the interests of patients and their families.
Valuing the contribution of staff and investing in their development.
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Valuing the diversity of all our staff, patients and carers and demonstrating a zero tolerance of
discrimination.
The importance of developing innovative approaches to teaching, research and service provision,
which allows us to be at the forefront of developments in patient care.
Responsible and wise stewardship of public money and effective use of resources.
VALUES AND BEHAVIOURS
Nottingham University Hospitals NHS Trust has a set of values and behaviours to improve the
experience for our patients and our staff (We are Here for You). This means that in undertaking this
role the post holder is expected at all times to behave in a way that demonstrates commitment to the
delivery of thoughtful patient care and continuous improvement as detailed in the table below.
Thoughtful Patient Care
Caring and Helpful
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Polite, respect individuals, thoughtful,
welcoming
Helpful, kind, supportive, don’t wait to be
asked
Listening, informing, communicating
Safe and Vigilant
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Clean hands and hospital, so patients
are safe
Professional, ensure patients feel safe
Honest, will speak up if needed to stay
safe
Clinically Excellent
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Best outcomes through evidence-led
clinical care
Compassionate, gentle, see whole
person
Value patients’ time to minimise waiting
Continuous Improvement
Accountable and Reliable
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Reliable and happy to be measured
Appreciative of the contribution of others
Effective and supportive team-working
Best Use of Time & Resources
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Simplify processes, to find more time to
care
Eliminate waste, investing for patients
Making best use of every pound we
spend
Innovation for Patients
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Empowerment to act on patient
feedback
Improvement led by research and
evidence
Teaching the next generation
KEY JOB RESPONSIBILITES
General
 Contribute to policy development for NUH.
 Maintain the suite of Research and Innovation standard operating procedures (SOPs), working
practices and guidance documents to ensure a robust quality management system within NUH.
 Review, implement and verify NUH working practices and standard operating procedures,
ensuring that all regulatory and Trust requirements are encapsulated.
 Maintain precise and accurate quality management records that are ready for inspection by
regulatory bodies and Sponsors on demand.
 Undertake quality assurance checks of research activity undertaken within NUH.
 Recognise and respond to research governance and quality issues that might arise during quality
assurance checks.
 Recognise and act upon departures from legislative and research governance requirements
including failure to follow protocols and/or SOPs, responding appropriately and escalating as
required.
 Promote a quality culture among NUH researchers.
 Attend national meetings on behalf of NUH.
 Liaise with all members of medical and non-medical staff regarding research quality assurance
issues.
 Maintain good working relationships with academic and service departments in order to promote
effective teamwork.
 Work autonomously.
 Ensure there is adequate and effective communication on quality assurance systems across NUH.
 Meet with the Research and Innovation Head of Regulatory Compliance on a regular basis to
provide feedback on staff, workload and quality assurance activity.
Education and Training
 Maintain a high level of knowledge relating to the EU and UK legislation, regulations, management
and conduct of research and act as the NUH expert on these matters.
 Provide support and advice to NUH researchers regarding ICH-GCP and compliance.
 Prepare and deliver targeted programmes of ICH-GCP, research governance, compliance and
quality management to departments involved in research and pharmacovigilance activities, and
other members of the Research and Innovation department.
Audits and Inspections
 Provide input into the development of the audit strategy and quality assurance function.
 Maintain and deliver the audit programme for the research and pharmacovigilance functions within
NUH to determine on-going compliance to ICH-GCP, regulatory requirements, research protocols
and NUH SOPs and policies.
 Interact with research teams, departments and vendors in order to perform:
 Investigator site audits,
 Vendor audits,
 Pharmacovigilance audits,
 Process audits,
 Documentation audits.
 Ensure that these audit activities are documented and that findings are disseminated within NUH
in order to drive continuous improvement to procedures.
 Support preparation for and facilitating external audits carried out by Sponsors and regulatory
bodies.
 Assist in providing responses to audit/inspection findings and coordinate corrective and
preventative actions.
 Assist in the preparation of reports for the Clinical Effectiveness Committee documenting audit
activities, metrics, findings and resolutions.
This list of responsibilities is not exhaustive, the post holder will be expected to undertake any other
relevant duties appropriate to the grading of the post.
GENERAL DUTIES
In addition to the key job responsibilities detailed in this job description, all employees at Nottingham
University Hospitals NHS Trust are expected to comply with the general duties detailed below:
Infection Control
To maintain a clean, safe environment, ensuring adherence to the Trust’s standards of cleanliness,
hygiene and infection control.
Safeguarding Children, Young People and Vulnerable Adults
Nottingham University Hospitals NHS Trust is committed to safeguarding and promoting the welfare of
children, young people and vulnerable adults. All staff and volunteers are therefore expected to
behave in such a way that supports this commitment.
Information Governance
All staff have an individual responsibility for creating accurate records of their work and for making
entries into and managing all NHS records effectively in line with the Health Records Keeping Policy
and other Health Records and Corporate Records Management policies and procedures in order to
meet the Trust’s legal, regulatory and accountability requirements .
Health and Safety
To take reasonable care to prevent injury to themselves or others who may be affected by their acts
or omissions.
To co-operate fully in discharging the Trust policies and procedures with regards to health and safety
matters.
To immediately report to their Manager any shortcomings in health and safety procedures and
practice.
To report any accidents or dangerous incidents to their immediate Manager and safety representative
as early as possible and submit a completed accident/incident form.
To use protective clothing and equipment where provided.
Whilst the aim of the Trust is to promote a co-operative and constructive view of health and safety
concerns in the organisation, all staff must be aware that a wilful or irresponsible disregard for safety
matters may give rise to disciplinary proceedings.
Governance
To actively participate in governance activities to ensure that the highest standards of care and
business conduct is achieved.
General Policies, Procedures and Practices
To comply with all Trust policies, procedures and practices and to be responsible for keeping up to
date with any changes to these.
WORKING CONDITIONS
This is an office based role requiring normal office hours to be worked. There will be travel to offices
and meetings, all expenses will be paid.
JOB REVISION
This job description should be regarded as a guide to the duties required and is not definitive or
restrictive in any way. The duties of the post may be varied from time to time in response to changing
circumstances. This job description does not form part of the contract of employment.
Service Review
A strategic review of all Trust services is taking place, as a result of which some services or parts of
some services may transfer from one campus to the other. This will be decided in accordance with
the most appropriate way to provide the best healthcare for patients in the future and all staff will be
fully consulted about the impact of any such decisions.
The Nottingham NHS Treatment Centre
The new Nottingham NHS Treatment Centre opened on the Queen’s Medical Centre Campus in late
July 2008. The Nottingham NHS Treatment Centre is run and managed by Nations Healthcare, an
Independent Sector Provider. A range of outpatient, day case and diagnostic services are
transferring into the Treatment Centre from Nottingham University Hospitals NHS Trust in a phased
way over a period of several months. As a result of this, the work that you do may be affected in one
of several ways:
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2.
3.
4.
Your work may not be affected at all.
You may be required to undertake work on behalf of the Treatment Centre.
You may be required to undertake some of your existing work in the Treatment Centre.
You may be seconded to work in the Treatment Centre.
Staff seconded to do all or some of their work in the Treatment Centre will remain the employees of
Nottingham University Hospitals NHS Trust and throughout the period of their secondment.
Job Description Reviewed:
Date:
May 2014