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Job Description
JOB DETAILS
Job Title Research Nurse/Practitioner
Reports to Team Lead/Research Nurse Specialist
Band 5
National Job Profile used
Department/Directorate Research & Development

JOB PURPOSE

We are seeking an experienced registered research nurse who has recent relevant clinical
experience to be part of the Clinical Research team. You will support the safe conduct of
research in accordance with the Research Governance Framework and Good Clinical
Practice guidelines and provide assurance that the rights, safety and well-being of trial
participants are protected.

The post-holder will work with the research team to plan, implement, organise and
manage concurrent research projects. S/he will develop networks with Multidisciplinary
Teams across the Trust and other appropriate local and national agencies. S/he will
coordinate and manage the relevant study portfolio and deliver recruitment accrual in line
with performance and monitoring objectives.

The post holder will be responsible for the implementation and monitoring of the clinical
requirements associated with research to ensure optimum delivery of clinical trials. S/he
will ensure that all research procedures are conducted according to study protocols and
will be accountable for the recruitment, data collection and care of research participants
with a focus on providing a quality experience.

KEY WORKING RELATIONSHIPS

Trust Lead Research Nurses
Trust Research Team Leads
Trust Pharmacy Trials Team
Trust Diagnostic Services
Trust Finance Team
Research and Development Department
Principal Investigators
Study participants and their families
Study sponsors and Clinical Research Associates
South West Peninsula Clinical Research Network
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ORGANISATIONAL CHART

KEY RESULT AREAS/PRINCIPAL DUTIES AND RESPONSIBILITIES

Leadership
• Manage research performance and study timelines of relevant studies.
• Collaborate with other Trusts and organisations within the region to improve
research delivery.
• Keep up to date with research management issues through liaison with other
Research Specialists /Team leaders and link with national networks.
• Provide relevant supervision and mentorship to members of staff and students.
• Take responsibility for own health, safety and security and promote the
health, safety and security of the wider team.
• Contribute to the development and implementation of clinical and research
policies, procedures and SOPs.
• Assist in the delivery of education and training regarding research for the wider
Multidisciplinary Team and act as an ambassador for research.
• Promote a blame free culture in reporting incidents and where appropriate support
local investigation of incidents.
Research
• Be responsible for the delivery of the clinical trial portfolio.
• Ensure that the delivery of studies meet requirements with regards to the
Department of Health’s Research Governance Framework for Health & Social
Care and the EU Clinical Trials Directive by implementing quality systems.
• Participate in Good Clinical Practice (GCP) training.
• Contribute to the Expression of Interest / Study Selection process for the relevant
specialty.
• Contribute to study set up, recruitment planning and study delivery.
• Be responsible for promoting the appropriate referral and recruitment of
patients to clinical research studies. Work with the clinical trials team and
investigators to develop strategies to overcome barriers to recruitment and to
solve other problems relating to specific studies.
• Coordinate and run study visits including off site visits whilst adhering to the lone
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worker policy.
• Work with other departments within the Trust to ensure that trial specific
investigations and procedures are undertaken as required by the trial protocol,
in order to establish eligibility and safety of patients within clinical trials.
• Contribute to the accurate costing for clinical trials and appropriate negotiation of
required financial support to deliver clinical trials.
• Ensure clear, accurate and concise records are kept for research projects in
accordance with all regulatory requirements including the Data Protection Act.
• Ensure that data is transcribed accurately where required and assist with the
maintenance of the Trial Master File.
• Respond to data queries generated by the study coordinating team within a timely
manner.
• Ensure the recording & reporting of adverse and serious adverse events that
occur whilst the participant is in the clinical trial to the trial co-
coordinator/Principal Investigator (PI) and R&D office in line with the study
protocol, local policies and regulatory requirements.
• Assess and evaluate the progress of on-going clinical trials for which the post
holder has responsibility, maintaining accurate records of the status of studies and
providing regular updates to the department on the status of the studies. This
will involve ensuring that EDGE (Local Patient Management System) is updated
with key trial data and validated efficiently.
• Escalate on-going study performance issues to the Senior Research Nurse or
Team Lead.
• Co-operate with external and internal audit, data monitoring and quality
assurance by working with R&D, sponsors, study monitors and external bodies.
• Assist in study close down and the preparation of results of research for
presentation as posters, abstracts, papers or scientific presentations.

Clinical & Professional

• Be responsible for the care of research participants within the relevant sphere of
practice and use opportunities to provide health promotion and patient education.
• Use relevant clinical knowledge to screen and identify patients suitable for clinical
research using inclusion and exclusion criteria and utilising NHS records,
screening clinics, visiting wards and outpatients and using Trust IT systems and
databases.
• Act as a resource and role model for all aspects of Research Clinical Practice in
order to optimise patient care and clinical practice this may include carrying out
physical assessments, conducting sample retrieval and processing, providing or
coordinating interventions and treatments, clinical monitoring.
• Undertake all mandatory training and take part in personal development reviews.
• Ensure the environment is suitable for patient care and research processes,
recognising the importance of privacy, dignity and diversity.
• Demonstrate professional development and an in-depth knowledge of current
clinical and research practice.
• Provide on-going advice and information to patients and their carers/families with
regard to their participation in clinical research in order to facilitate effective
informed consent.
• Where appropriate receive and document written informed consent from research
subjects.
• Training and support for informed consent will be given. Be responsible for the safe
and accurate collection of research data through clinical procedures such as
venepuncture, history taking, standard observations (height, weight, BP, RR, HR,
SpO2 temperature) and other assessments such as ECG, physical
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examinations, disease specific outcome measures, questionnaires, rated scales,

qualitative interviewing as required by the protocol.
• Centrifuge, process track and ship samples in line with protocol requirements.
• Ensure the safe administration of any treatments and drugs given within the
context of a clinical trial.
• Monitor treatment toxicity/side effects and initiate changes to treatment as
required by the protocol. Escalate any concerns to the Principle Investigator or
relevant physician.
• Ensure accurate patient trial documentation, including the use of electronic data
capture systems and ensure relevant information is recorded in patients’ medical
notes and case report form in a timely manner.
• Refer to other specialists as required in order to provide optimal care of the
participant.
• Contribute to the monitoring of clinical standards within the research team.
• Treat all persons encountered during the course of duties with respect and
courtesy and maintain a standard of conduct which best represents the clinical
trials team and the Trust.
• Work within the relevant professional code of conduct (if applicable)
demonstrating accountability for own actions and awareness of own limitations.
• Supervise the work of junior members of staff and delegate work where
appropriate.
• Provide cover for other research nurses/ practitioners as required.
• Proactively seek feedback from participants and their families during their research
involvement.
Resources
• Have an awareness of the income stream relevant to Clinical Trials and work
within, local and Trust wide financial and budgetary guidelines.
• Assist in accurate costings for clinical research activity during study set up. Utilise
planning tools such as the intensity toolkit.
• Assist in identifying resource implications for individual studies.
• Ensure research equipment is maintained in an effective working and good clinical
order.
COMMUNICATION/RELATIONSHIP SKILLS
• Facilitate and maintain effective communication within the research team and
between the multidisciplinary clinical team.
ANALYTICAL/JUDGEMENTAL SKILLS
• Clinical knowledge within a relevant sphere of practice is required to enable screening
against specified inclusion/exclusion criteria for recruitment.
• Post-holder will need to have relevant clinical knowledge and the ability to critically
evaluate participant’ progression through research pathways in order to respond and
refer appropriately.
• Critical research evaluation and the ability to conduct feasibility will be key requirements
when working on research protocols.
• Engage in early evaluation of Expressions of Interest (EOI) received with Principal
Investigator and team lead to ensure feasibility of study at site is properly assessed.
• Work with the lead clinician and senior research nurse/team lead to review complex
clinical trial protocols and to develop a balanced portfolio of studies for each speciality
that the post holder works across.
PLANNING/ORGANISATIONAL SKILLS
• Be responsible for managing and organising own day-to-day activities and workload,
liaising with the senior research nurse and working within the team to ensure the
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portfolio remains covered at times of leave.

• Deputises for senior research nurse on an ad hoc basis.
• Supports the planning of both short-term and long-term research projects.
• Works with the Team Lead to understand and plan the portfolio of studies that may be
open, in follow up or in set up at any one time.
• The post–holder will be able to work autonomously whilst ensuring that all research
procedures are conducted according to study protocols and Standard Operating
Procedures (SOP), both Trust and study specific.
• If working alone the post-holder will adhere to the Trust’s Lone Worker SOP and the
speciality’s Working Instructions.
PHYSICAL SKILLS
• The post holder will be required to use their excellent IT skills including MS Office, Google
docs, internet, databases etc. in order to monitor activity, systems and processes and to
produce reports including in time-bound circumstances.
• Standard keyboard skills are required for the inputting and manipulating of data and/or
information on computer databases.
PATIENT/CLIENT CARE
• The post holder will contribute to ensuring the patient experience is excellent ensuring
patients are at the heart of service design and delivery.
• Ensure Trust policies are applied in the Clinical Team support reporting of complaints
and concerns by research participants that may be related to their participation in
research and to ensure these complaints are appropriately managed and acted upon in
accordance with requirements of the UK Policy Framework for Health and Social Care
Research.
POLICY/SERVICE DEVELOPMENT
• Promote a culture of continuous improvement and transformation, enabling all change
management activity, providing expertise, advice and guidance to staff and working with
staff groups and change champions as required.
FINANCIAL/PHYSICAL RESOURCES
• Frequent requirement to exert moderate physical effort. Research offices are not based
where patients are seen or recruited and the research team members are required to
work across multiple sites at the RDE Wonford and where necessary Heavitree.
• Contribute to the accurate costing for clinical trials and appropriate negotiation of
required financial support to deliver clinical trials.
• Ensure that participants can claim appropriate travel and other expenses and
completing invoices in a timely and accurately.
HUMAN RESOURCES
• Supervise band 4 Assistant Research Practitioners and a range of junior staff.
• Support senior staff in recruitment and interviewing processes in line with Trust
practices and procedures.
• Take an active role in the mentoring and supervision of student nurses and junior staff
• Provides teaching in practice to other staff and students through clinical supervision and
facilitation.
• Assist in the delivery of education and training regarding research for the wider
Multidisciplinary Team and act as an ambassador for research
INFORMATION RESOURCES
• Ensure clear, accurate and concise records are kept for research projects in accordance
with all regulatory requirements including the Data Protection Act.
• Ensure that data entry is accurate.
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• Respond to data queries generated by the study coordinating team within a timely
manner.
• Demonstrate awareness of the Ethics Committee Procedures through prompt reporting
of Serious Adverse Events, submission of Trust application, protocols, advertisements
and amendments.
RESEARCH AND DEVELOPMENT
• Demonstrate awareness of R&D/CRF facilities within the Trust and their working
relationships
• Demonstrate awareness of the Ethics Committee Procedures through prompt reporting
of Serious Adverse Events, submission of Trust application, protocols, advertisements
and amendments.
MENTAL EFFORT
• Data accuracy and IT skills are essential to this role and combining clinical skills with
these demands can be mentally difficult. Undertaking data entry is a requirement for
this role and can often require long periods of concentration.
• There can be occasional requirements for intense concentration when performing IT
training for a new study requiring mastering a series of IT programmes.
EMOTIONAL EFFORT
• Rare exposure or occasional indirect exposure to distressing/emotional circumstances.
• On occasion the post holder maybe required to undertake discussions about research
with participants and their families during times of emotional distress
WORKING CONDITIONS
• The role requires flexibility as the research offices are not necessarily based where the
patients are recruited or seen for their clinical research appointments.
• Attending Investigator Meetings can mean traveling around the country or even abroad.
Travel arrangements are made and costs covered by the sponsors and commercial
companies but flexibility is required in order to accommodate attending these meetings.
• The post-holder maybe required respond to an incidence driven recruitment strategy
and this may be achieved through use of a bleep, group WhatsApp, text, and phone
call.
• Covering a multi Trust site portfolio or performing home visits will mean the post-holder
is required to ensure they can commit to this requirement.
FREEDOM TO ACT
• The post holder will work autonomously within general policies and procedures guided
by national policy and regulations and the Trust’s own policies.

OTHER RESPONSIBILITIES
• To take part in regular performance appraisal.
• To undertake any training required in order to maintain competency including
mandatory training, e.g. Manual Handling
• To contribute to and work within a safe working environment
• The post holder is expected to comply with Trust Infection Control Policies and conduct
him/herself at all times in such a manner as to minimise the risk of healthcare associated
infection
• As an employee of the Trust, it is a contractual duty that you abide by any relevant code
of professional conduct and/or practice applicable to you. A breach of this requirement
may result in action being taken against you (in accordance with the Trust’s disciplinary
policy) up to and including dismissal.
APPLICABLE TO MANAGERS ONLY
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•
THE TRUST- VISION AND VALUES
Our vision is to provide safe, high quality seamless services delivered with courtesy and
respect. To achieve our vision we expect all our staff to uphold our Trust values. Our Trust
values are:
Honesty, Openness & Integrity
Fairness,
Inclusion & Collaboration
Respect & Dignity
We recruit competent staff that we support in maintaining and extending their skills in
accordance with the needs of the people we serve. We will pay staff fairly and recognise the
whole staff’s commitment to meeting the needs of our patients.
We are committed to equal opportunity for all and encourage flexible working arrangements
including job sharing.
We are committed to recruiting and supporting a diverse workforce and welcome applications
from all sections of the community, regardless of age, disability, gender, race, religion, sexual
orientation, maternity/pregnancy, marriage/civil partnership or transgender status. We
expect all staff to behave in a way which recognises and respects this diversity, in line with
the appropriate standards.
GENERAL
The nature of clinical research is such that flexibility is required from the workforce.
Periodically it may be necessary to move staff within the different specialties in order to meet
the needs of the portfolio and maintain the required skill mix. The Patient Recruitment Centre
provides a flexible service to research participants including the opportunity for evening and
weekend appointments, the post holder will need to be flexible with working patterns in order
to meet participant and study requirements.
This is a description of the job as it is now. We periodically examine employees' job
descriptions and update them to ensure that they reflect the job as it is then being performed,
or to incorporate any changes being proposed. This procedure is conducted by the Manager
in consultation with the jobholder. You will, therefore, be expected to participate fully in such
discussions. We aim to reach agreement on reasonable changes, but if agreement is not
possible, we reserve the right to insist on changes to your job description after consultation
with you.
The RD&E is a totally smoke-free Trust. Smoking is not permitted anywhere on Trust
property, including all buildings, grounds and car parks. For help to quit call: 01392 207462.

POST Research Nurse

BAND 5
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Personal Specification
REQUIREMENTS At At 2nd KSF
Recruitment Gateway
QUALIFICATIONS/SPECIAL TRAINING:
Registered Nurse E E
Research Training (e.g. GCP, degree module, informed consent) D E
Up to date professional portfolio E E

KNOWLEDGE/SKILLS:
Good understanding of nursing care methods and models E E
Understanding of data collection and data entry for clinical trials D E
Pertinent clinical skills D E
Understanding
IV odata collection and data entry for clinical trials
Drug Administration D E
Computer literacy including ability to work with databases E E
Ability to organise and prioritise own workload and work to tight E E
deadlines
Ability to make independent decisions E E
Understand the significance of research and use of validated results to E E
improve practice
Skilled at clinical observations and venepuncture D E
Knowledge of Research Governance Framework and Good Clinical D E
Practice Guidelines
Knowledge of clinical trials and research methodologies D E
EXPERIENCE:
Experience with dealing with confidential patient information E E
Ability to communicate complex information to patients/carers/ E E
members of MDT
Broad and recent clinical experience relevant to the post E E
Proven record of meeting targets D E
Experience of clinical research within the NHS setting D E
PERSONAL REQUIREMENTS:
Ability to work autonomously E E
Ability to work cohesively as a member of a multidisciplinary team E E
High level of interpersonal and communication skills E E
Flexible and adaptable E E
Willingness to learn, instigate and develop efficient working systems E E
Willingness to undertake any necessary training and development to E E
enhance work performance
Commitment to openness, honesty and integrity in undertaking the E E
role
Willingness and ability to work across sites including community E E
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FREQUENCY

(Rare/ Occasional/
Moderate/ Frequent)
WORKING CONDITIONS/HAZARDS R O M F

Hazards/ Risks requiring Immunisation Screening

Laboratory specimens Y ✓
Contact with patients Y ✓
Exposure Prone Procedures Y ✓
Blood/body fluids Y ✓
Laboratory specimens Y ✓

Hazard/Risks requiring Respiratory Health Surveillance

Solvents (e.g. toluene, xylene, white spirit, acetone, formaldehyde N

and ethyl acetate)
Respiratory sensitisers (e.g isocyanates) N
Chlorine based cleaning solutions N
(e.g. Chlorclean, Actichlor, Tristel)
Animals N
Cytotoxic drugs N

Risks requiring Other Health Surveillance

Radiation (>6mSv) N
Laser (Class 3R, 3B, 4) N
Dusty environment (>4mg/m3) N
Noise (over 80dBA) N
Hand held vibration tools (=>2.5 m/s2) N

Other General Hazards/ Risks

VDU use ( > 1 hour daily) Y ✓
Heavy manual handling (>10kg) N
Driving Y ✓
Food handling N
Night working N
Electrical work N
Physical Effort N
Mental Effort Y ✓
Emotional Effort Y ✓
Working in isolation N
Challenging behaviour N