Research Nurse

Job responsibilities

JOB PURPOSE

The National Institute for Health Research (NIHR) is funded through the Department of Health to improve the health of the nation through research. The NIHR Clinical Research Network (CRN) is the clinical research delivery arm of the NHS in England, tasked with supporting the rapid set-up and effective conduct of studies to enable researchers to gather the robust evidence needed to improve treatments for NHS patients. The NIHR Clinical Research Network operates through 15 Local Clinical Research Networks (LCRNs) which drive clinical research delivery performance. The CRN West of England is one of these local Clinical Research Networks.

The postholder will support the management and delivery of research within the practice. S/he will work alongside the GP research lead and research administrator to ensure the safe and effective delivery of clinical research studies. S/he will have knowledge and understanding of the regulatory and legal frameworks related to the planning, undertaking and closure of clinical research studies, or will be willing to undertake training to develop these skills. The postholder will have excellent communication skills to foster good working relationships in research sites.

The role is based at Cadbury Heath Healthcare in South Gloucestershire.

MAIN DUTIES AND RESPONSIBILITIES

Study Set Up

Ensure all elements of set up are completed in accordance with UK and EU legal requirements, practice policies and Good Clinical Practice, as appropriate, whether conducted personally or through appropriate delegation.

Provide advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory approval.

Have a knowledge and understanding of research design and methodology.

Contribute to the assessment of study protocols and advise on any safety, regulatory and logistical issues.

Provide oversight for the set-up of research studies within the team, acting as point of contact for the CRN in the feasibility process.

Project manage study set up in collaboration with the GP research lead and research administrator.

Study conduct

Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study.

Promote open studies to colleagues within the practice to optimise recruitment.

Identify and screen appropriate study participants, in accordance with the protocol, and in conjunction with other members of the clinical and research team.

Take informed consent for designated research studies as agreed within the protocol.

Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations.

Provide knowledge and demonstrate accurate attention to detail in documentation tasks, to include:

o Investigator Site File maintenance

o CRF completion

o Documenting source data

Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the team, and wider research community as appropriate.

Ensure all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP and study protocols.

Where appropriate, liaise with the CRN and study teams in identifying any blockages to recruitment and the running of the trial; support the study team in developing strategies to mitigate them.

Support the study team in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner.

Support the study team to ensure that all research study equipment used is appropriately checked and calibrated with supporting documentation retained.

Liaise with Sponsors to ensure all arrangements for research governance for each study are in place.

Study End

Ensure all data clarification issues are resolved quickly.

Support the research administrator to ensure correct archiving of study related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations/ISO 14155 as appropriate.

Where appropriate, ensure a smooth transition from the research pathway back to the conventional treatment pathway.

Education

Identify own learning needs and proactively seek educational opportunities to fulfil them.

Strategic Role

Be a champion of clinical research within the practice

Support and influence the embedding of clinical research within the practice

Foster good relationships with members of the practice staff to promote the efficient running of clinical studies and develop the practice research portfolio

Contribute to the development and updating of practice research policies

SUPERVISION RECEIVED

The postholder will be operationally line managed by Dr Lucy Pocock.

KEY WORKING RELATIONSHIPS

Develop and maintain key working relationships with:

Research administrator

Practice GPs, Practice Nurses, Pharmacists, Paramedic Practitioners and HCAs

Patients and Carers

Practice Management, Reception and other Administrative staff

Clinical Research Network colleagues

Secondary Care and interface colleagues

Community Nurses and other allied health professionals

Community Pharmacists and support staff

Social prescribing link workers

Voluntary sector colleagues

CONFIDENTIALITY

Under the Data Protection Act 2018 (alongside the EU General Data Protection Regulations) the postholder must maintain the confidentiality of information about patients and staff. The work is of a confidential nature and information gained must not be communicated to other persons except in the recognised course of duty. Unauthorised disclosure of confidential information may result in disciplinary action and may lead to your dismissal.

EQUALITY & DIVERSITY

The postholder will support the equality, diversity and rights of patients, carers and colleagues, to include:

Acting in a way that recognises the importance of peoples rights, interpreting them in a way that is consistent with the networks, procedures and policies, and current legislation.

Respecting the privacy, dignity, needs and beliefs of patients, carers and colleagues.

Behaving in a manner which is welcoming to and of the individual, is non-judgemental and respects their circumstances, feelings, priorities and rights.

HEALTH & SAFETY

Employees must be aware of the responsibilities placed on them under the Health & Safety at Work Act (1974) to ensure that the agreed procedures are carried out to maintain a safe environment for patients, visitors and staff, including infection prevention and control.

12. SAFEGUARDING

To be fully aware of and understand the duties and responsibilities arising from the Childrens Act 2004 and Working Together in relation to child protection and safeguarding children and young people as this applies to the workers role within the organisation.

To also be fully aware of the principles of safeguarding as they apply to vulnerable adults in relation to the workers role, which will include recognising the types and signs of abuse and neglect and ensuring that the workers line manager is made aware and kept fully informed of any concerns which the worker may have in relation to safeguarding adults and/or children.

REHABILITATION OF OFFENDERS ACT

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 to check for any previous criminal convictions.

CONTINUING PROFESSIONAL DEVELOPMENT

The postholder should undertake appropriate CPD to retain their professional registration. The Practice will support the postholder to complete this requirement.

This job description is not meant to be finite and may be changed subject to the exigencies of the service. Similarly, the postholder may be requested to undertake such other duties not mentioned in the job descrip

Skills & Knowledge

Essential

• Good written and spoken English
• Able to communicate complex information to other professional groups e.g., communicating with sponsors representatives
• Ability to work autonomously and as part of a team
• Able to prioritise and manage own workload
• Able to exercise own initiative when dealing with issues within own specialist area
• Good computer literacy
• Evidence of continuing professional development
• Knowledge of requirements of Good Clinical Practice and Research Governance

Desirable

• Proven understanding of clinical governance and risk management, its importance and application

Qualifications

Essential

• Registered Nurse

Desirable

• ICH Good Clinical Practice qualification
• Postgraduate qualification in relevant subject

Experience

Essential

• Significant post registration nursing experience
• Experience of formal/ informal teaching of patients and staff
• Experience in delivering evidence based practice
• Experience of explaining complex concepts to patients in a clear and simplified manner
• Recent experience of phlebotomy and cannulation
• Experience in clinical assessment (vital signs, ECGs etc)

Desirable

• Clinical research experience
• Experience of clinical audit
• Experience working as a preceptor/facilitator

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.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).