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JOB DESCRIPTION
1.
General Information
JOB TITLE:
Clinical Research Nurse
GRADE:
Band 6
HOURS:
37.5 hours per week
RESPONSIBLE TO:
Bioresource Coordinator
PROFESSIONALLY
ACCOUNTABLE TO:
Modern Matron for Research/Bioresource Lead
Guy’s & St Thomas NHS Foundation Trust
Guy’s and St Thomas’ is one of the largest hospital trusts in the country, with a staff of
almost 12,000, a turnover of over £1 billion and one million patient contacts a year.
The Trust comprises two of London’s oldest and best known teaching hospitals. The
hospitals have a long history, dating back almost 900 years, and have been at the forefront
of medical progress and innovation since they were founded. Both hospitals have built on
these traditions and continue to have a reputation for excellence and innovation.
We are part of King’s Health Partners Academic Health Sciences Centre (AHSC), a
pioneering collaboration between one of the world’s leading research-led universities and
three of London’s most successful NHS Foundation Trusts. Our AHSC is one of only five
in the UK. It consists of King’s College London, and Guy’s and St Thomas’, King’s College
Hospital and South London and Maudsley NHS Foundation Trusts. King’s Health Partners
includes seven hospitals and over 150 community based services, is responsible for
seeing 2 million patients each year, has 25,000 employees and 19,500 students, and a £2
billion annual turnover. It brings together the best of basic and translational research,
clinical excellence and world-class teaching to deliver groundbreaking advances in
physical and mental healthcare. See www.kingshealthpartners.org
From 1 April 2011, the management of community health services in Lambeth and
Southwark transferred from the local Primary Care Trusts to Guy’s and St Thomas’ NHS
Foundation Trust, marking a new era for community services locally.
The integration of community services into GSTT provides an opportunity for staff to help
shape services so they better suit patient needs, balance demands across the whole
system and create a seamless care pathway for patients.
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South London Comprehensive Local Research Network
The NIHR Comprehensive Clinical Research Network (CCRN) was established by the
Department of Health to improve the speed, quality and integration of clinical research,
resulting in improved patient care. It is managed by the NIHR Clinical Research Network
Coordinating Centre, based in Leeds and London. The NIHR CCRN comprises 25 local
research networks (CLRNs) in England, each including primary care, secondary care,
tertiary care and mental health NHS service providers.
The role of the CLRNs is to establish and maintain an excellent NHS infrastructure for
clinical research and research management. This infrastructure includes clinical research
support staff and sessional support for clinical investigators of all professions, funding for
other NHS Support Costs such as additional clinical services and diagnostic tests, and
research management and governance systems and staff.
The NIHR Biomedical Research Centre at GSTFT and KCL
The NIHR Biomedical Research Centre (BRC) at GSTFT and KCL has recently been
awarded a further £58.7M over the period 2012-2017 as part of the Department of Health’s
strategy for Research & Development to deliver world class translational research to
benefit the health and wealth of the nation. The first GSTFT/KCL BRC award from April
2007-2012 allowed us to establish of state of the art research infrastructure including the
development of an Experimental Medicine Hub at Guy’s Hospital. The new BRC’s
research is strategically integrated and managed by five Research Clusters: Experimental
Medicine and Therapeutics; Biomarkers, Co-diagnostics and Imaging; Population
Sciences; the School of Translational and Experimental Medicine (STEM) and the
Operational Infrastructure Cluster. Research within these Clusters are based around eight
outstanding research themes encompassing Cancer; Cardiovascular Disease; Cutaneous
Medicine; Environmental and Respiratory Health; Imaging & Bio-Engineering; Infection &
Immunity; Translational Genetics; and Transplantation.
The Experimental Medicine Hub houses state of the art facilities for the delivery of
translational research and includes the BRC/R&D Department Management offices,
CLRN, PCRN, Joint Clinical Trials Offices creating a one stop shop for researchers, as
well as the CRF at Guy’s, Immune Monitoring Core, Good Manufacturing Practice (GMP)
Cell Therapy Suite and Genomics Core, as well as Quintiles Phase I Clinical Trials Unit,
GMP Pharmacy, the Assisted Conception Unit with a GMP stem cell suite a GMP Flow
Sorting Core and BRC Imaging Core.
The Biomarkers, Co-Diagnostics & Imaging Cluster provides interdisciplinary skills in
biomarker discovery, biobanking, co-diagnostics, imaging and proof of principle clinical
trials. Translational Genetics will transform the impact of translational biomarker research.
The Cluster will provide an integrated platform for a step change in innovative
development of novel biomarkers and co-diagnostics. Three initial programmes including
Biomarkers and Co-diagnostics in chronic inflammatory disease and transplantation;
Biomarkers in Cardiovascular (CV) Disease and Multimodality cancer imaging will take
advantage of expertise in disease relevant pathways and biobanking to establish
correlative biomarkers with clinical interventions in an iterative “learn and confirm”
approach.
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NIHR Bioresource for Kings Health Partnership (KCL/GSTT/KCH)
The London Bioresource sits within the KHP BRC. Professor Tim Spector is the designated lead
of the local Bioresource.
The Bioresource already contains a number of patient research resources. As part of the national
initiative for recallable normal populations - the Bioresource houses the TwinsUK resource as part
of the NIHR strategy . This consists of 7000 adult twins of North European ancestry aged 17 to 99
who have provided at least one DNA and fasting blood sample and in many cases multiple
samples. The sample have been extensively tested as part of other genomic research programs.
Other combined NIHR Projects include
 The National NIHR exome chip project - 1400 informative twins have been selected for
assay by the exome chip.
 Consents and recall. Exisitng patient resources are being re-contacted to obtain consent for
NIHR recall studies. Planning is underway to standardise consents and information sheets
across the BRC with a view to a standard accepted consent with an opt-out for all patients
within the trusts.
 Disease specific projects. Currently discussions are still ongoing about which diseases will
be taken forward and collected by all the BRCs. Potentially 1000 HIV cases are available
for collection of blood, extraction of DNA with consent. Other proposals for local or national
collections include- allergies- including nickel allergy, psoriasis (mentioned above), CVD
correlates of inflammatory diseases, and immune changes in chronic pain syndromes.
 Recallable resource based on genotype.
 Recruiting local twins. An ongoing publicity campaign has started to attract both local and
ethnic twins to the NIHR resource. The local press and TV has been involved - with over 30
new pairs recruited to date.
 Biobanking for the Bioresource studies. A search for a central storage facility has started
and KCL and the trust are committed to providing this long term solution within 12 months.
Organisational Values:
The post holder will:
 Put patients first - consider the patient’s
needs and wishes in all that they do
 Take pride in what they do – strive for
highest standards on own work and
challenge colleagues to do the same
 Strive to be the best – in terms of patient
care & teamwork
2.
 Act with integrity - maintain the privacy &
dignity of patients, work with integrity and be
trustworthy, be accountable for own work
 Respect others – patients, visitors and
colleagues. Actively give and receive
feedback .
Job Summary
Assess, plan, implement, and evaluate expert research nursing care and provide support to
patients/volunteers attending KHP units who have been or have the potential to be recruited onto
the KHP Bioresource. The Research Nurse will play a key role in ensuring that any research
undertaken safeguards the well being of the patients and is conducted according to Good Clinical
Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended
Regulations 2006. In conjunction with the other members of the team, facilitate the production of
good quality of research.
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The research nurse will facilitate and aid in the recruitment of patients/volunteers to ensure high
quality clinical studies and trials which will require the nurse to work flexibly across the disciplines
to ensure the successful working of the research projects they are assigned to. They will also act
as a patient advocate providing support and assistance as required and assist in the co-ordination
and management of a portfolio of clinical research studies.
The post holder will take responsibility for the safe administration of experimental therapies, and for
monitoring the expected and unexpected side effects of drugs and other treatment modalities used
in these trials.
3.
Key Relationships
Bioresource Coordinator, Bioresource Lead, Research Nurse Manger Department of Twin
Research, Cambridge Bioresource staff, Modern Matron for Research, Clinical Research Facility
Nurse Manager, Consultants and Lead Academics, Junior Medical Staff, Nursing Staff, Clinical
Nurse Specialists, Allied Health Professionals, Administrative and Clerical Support Staff,
Professional and Technical staff. Staff within non commercial bodies and Pharmaceutical
companies and/or sponsors.
4.
Duties and Responsibilities
Clinical

Carry out planned care required by the clinical and research project protocols for a group of
volunteers without direct supervision

Ensure the assessment, planning, implementation and evaluation of evidence based,
individualised patient/volunteer care.

Responsible for recruiting to, and following up, patients within studies. This includes both
randomised clinical trials and other high quality research studies. The role will involve
working closely with multidisciplinary clinical teams

Act as a patient advocate enabling patients to make informed choices concerning their
involvement in the clinical trials and ensuring advice and information is provided.

Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring
that they are carried out within the Trust and Centre's policies and clinical trial protocol.

Assist in research and clinical trials including venepuncture and cannulation of volunteers
when necessary ensuring that they are carried out within the Trust’s policies, research
governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and
Amended Regulations 2006 Incorporating International Conference on Harmonisation of
Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act.

Undertake clinical tasks such as phlebotomy, analysis of blood specimens, drug
administration and clinical observation etc.

Assist and advise staff, both registered and unregistered in the delivery of care to the
volunteer.

Ensure that written informed consent has always been obtained for any treatment provided
for, or any sample or data taken from a Volunteer which will form part of a research study,
in accordance with the Trust research governance arrangements and Medicines for Human
Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations
2006Incorporating International Conference on Harmonisation of Good Clinical Practice
(ICH GCP)

Have responsibility for the correct administration and custody of medicines according to
Trust policy.

Maintain all data and case report forms relating to research and clinical trials in accordance
with the Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and
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Amended Regulations 2006 Incorporating International Conference on Harmonisation of
Good Clinical Practice (ICH GCP) and the Research Governance Framework.

Report any deviation from normal practice to senior staff and implement agreed changes in
care programme.

Deal with concerns raised by volunteers and visitors in a proactive manner and take
remedial action as necessary.

Act as the volunteers advocate
Administration

Plan, organise and deploy staff according to ability and workload in order to meet volunteer
needs.

Ensure that nursing practices comply with Trust policies and procedures

Communicate effectively at all times and maintain a harmonious working environment.

Maintain a safe environment in accordance with the Health and Safety at Work Act.

Assist senior staff in managing incidents, accidents and complaints in accordance with
Trust policies and procedures.

Assist in ensuring the availability of resources for volunteer care

Ensure equipment is in good working order, and report appropriately when defective

Participate in audits, EG those undertaken by the Medicines and Health Care Regulatory
Authority (MHRA) nursing audits and clinical benchmarking exercises and suggest any
change to improve standards

Ensure the economical use of resources

Ensure the safe custody of volunteers property in accordance with Trust policies.

Promote and participate in the implementation of policies within the Centre and to ensure
compliance with Trust, Government and EU Directives.

Maintain accurate documentation in research and clinical trial documents and patient notes.

Ensure that clinical trials are effectively archived as required.

Assist in the process of gaining local regulatory committee approval (ethics and R&D
approval).
Education and Training

Assist in the education and support of health care professionals to enable them to care for
clinical trial patients and recruit to clinical trials where appropriate.

Maintain an up to date knowledge of research related topics particularly related to clinical
trials.

Attend local and national meetings as appropriate and as agreed with the local coordinating centre.

Attend regular update sessions when appropriate at GSTT/NIHR Bioresource National and
local meetings.

Assess the needs of volunteers, relatives and carers and provide them with information as
requested.

Educate and counsel volunteers, family and those who volunteer for research and clinical
trials before, during and after clinical studies and investigations.
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Other

Understand and adhere to KHP & Trust policies and procedures.

To maintain patient confidentiality and standards of Good Clinical Practice (GCP) at all
times.

Maintain NMC registration
Nature and Scope of Job
Post holders will assist in recruiting patients to research studies within the NIHR local and national
Bioresource centres. They will work closely with the Lead Clinicians/Academics in the individual
centres to which they are assigned, and with the coordinating centres within Kings Health
Partnership. They will attend co-ordinating centre meetings on a regular basis for study updates
and meetings with the coordinating staff.
The post holder is required to follow Trust policies and procedures which are regularly updated
including:
Confidentiality / Data Protection / Freedom of Information
Post holders must maintain the confidentiality of information about patients, staff and other health
service business in accordance with the Data Protection Act of 1998. Post holders must not,
without prior permission, disclose any information regarding patients or staff. If any member of
staff has communicated any such information to an unauthorised person those staff will be liable to
dismissal.
Moreover, the Data Protection Act 1998 also renders an individual liable for
prosecution in the event of unauthorised disclosure of information.
Following the Freedom of Information Act (FOI) 2005, post holders must apply the Trust’s FOI
procedure if they receive a written request for information.
Equal Opportunities
Post holders must at all times fulfil their responsibilities with regard to the Trust’s Equal
Opportunities Policy and equality laws.
Health and Safety
All post holders have a responsibility, under the Health and Safety at Work Act (1974) and
subsequently published regulations, to ensure that the Trust’s health and safety policies and
procedures are complied with to maintain a safe working environment for patients, visitors and
employees.
Infection Control
All post holders have a personal obligation to act to reduce healthcare-associated infections
(HCAIs). They must attend mandatory training in Infection Control and be compliant with all
measures required by the Trust to reduce HCAIs. All post holders must comply with Trust
infection screening and immunisation policies as well as be familiar with the Trust’s Infection
Control Policies, including those that apply to their duties, such as Hand Decontamination Policy,
Personal Protective Equipment Policy, safe procedures for using aseptic techniques and safe
disposal of sharps.
Risk Management
All post holders have a responsibility to report risks such as clinical and non-clinical accidents or
incidents promptly. They are expected to be familiar with the Trust’s use of risk assessments to
predict and control risk, as well as the incident reporting system for learning from mistakes and
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near misses in order to improve services. Post holders must also attend training identified by their
manager, or stated by the Trust to be mandatory.
Safeguarding children and vulnerable adults
Post holders have a general responsibility for safeguarding children and vulnerable adults in the
course of their daily duties and for ensuring that they are aware of the specific duties relating to
their role.
Smoking Policy
It is the Trust’s policy to promote health. Smoking, therefore, is actively discouraged. It is illegal
within Trust buildings and vehicles.
Review of this Job Description
This job description is intended as an outline of the general areas of activity and will be amended in
the light of the changing needs of the organisation. To be reviewed in conjunction with the post
holder.
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PERSON SPECIFICATION
Bioresource Research Nurse – Band 6
Education/
Qualifications
Previous
experience
ESSENTIAL
A/I/T*
Level 1 Registered Nurse
NMC Registration with previous
acute NHS experience
A
Educated to degree/diploma
level or above
A
Relevant specialist course or
equivalent experience
A
Extensive experience of working
within a ward environment as a
qualified nurse
A
Previous post registration
experience within the relevant
specialty
A
Experienced and competent in
the management of patients
within the speciality
A
Access
A
Excel
patient
A
Experience
of
effective
multidisciplinary team working
A/I
Extensive experience of working
in an acute NHS setting.
A
Experience of teaching
colleagues and staff
A
Experience
Databases
with
Experience
with
Spreadsheets,
and
database systems
A/I
DESIRABLE
A Clinical Research qualification
A
Post registration experience in a
relevant specialty
A
Experience in Clinical Research
A
Familiar with Good Clinical Practice
& Certification
A
Experience
capture.
A
of
electronic
data
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Skills/Knowledge/
Ability
Extensive knowledge
therapeutic speciality
Knowledge
methodologies
of
of
a
research
I
Knowledge of NMC Code of
Professional Conduct
I
Competency in medication
administration including IV drugs.
A/I
Organisation and management
skills.
A/I
Ability to lead a team.
A/I
Articulate with advanced written
and oral communication skills.
A/I
Ability to work effectively under
pressure.
I
Ability to problem solve.
I
Ability to perform clinical
activities specific to speciality.
I
Flexible
approach
towards
teamwork and patient/family
involvement
Enthusiastic,
accountable
A=application
I=interview
T=Test/ assessment centre
I
Knowledge of quality, standard
setting, benchmarking and audit.
IT skills including use of email
and office packages.
Additional
Information
A/1
profession
and
I
I
I