Clinical Research Nurse

The Christie International; Manchester; On-site; GBP 32,000 - 42,000; Full time

Job summary

The Christie NHS Foundation Trust in Manchester is seeking a Clinical Research Nurse to support a Breast Research portfolio, coordinating trials from feasibility to patient recruitment within a multidisciplinary team.

You will manage complex patient needs, ensure protocol compliance, and contribute to professional development in a leading cancer care setting with strong education and development support.

Qualifications

• Registered General Nurse – currently registered with the Nursing & Midwifery Council (NMC).
• First Degree or relevant clinical experience.
• Post-graduate qualification in oncology and/or clinical research.
• GCP/ICH recognised recent training.

Responsibilities

• Work autonomously in all areas of practice relating to clinical research.
• Deliver care in accordance with approved clinical research protocols.
• Obtain NHS permissions (R&D) prior to patient recruitment as project lead.
• Participate in trial feasibilities and risk assessments.
• Record clinical trial activities in appropriate systems in a timely manner.
• Recruit patients and ensure targets for recruitment are met.

Skills

Communication skills

Organisational skills

Written and analytical skills

Autonomous working

IT skills

IV chemotherapy administration

Education

Nursing degree (RGN)

Post-graduate qualification in oncology/clinical research

GCP/ICH training

Tools

Word

PowerPoint

Excel

Outlook

Job description

This post presents an excellent opportunity to join the establishing and expanding Breast Research team with a varied portfolio of early and late clinical trials as a Clinical Research Nurse (CRN).
Research nursing is an exciting and developing role, supported through the R&I division with a good education and development package in place to ensure that staff reach their potential.
Central to this role is the responsibility of assessing and managing the complex needs of patients participating in a clinical trial, including the delivery of all specified treatments for participants in research within a multidisciplinary team. Key responsibilities of the post include the coordination of the trial protocols and working alongside the clinical trial coordinators.
A background in oncology, flexibility in working, excellent communication and interpersonal skills are essential. Experience in clinical research and/or breast malignancies would be desirable.
An informal discussion about the post is strongly recommended with the possibility to spend some time with the team to understand better the requirement of the role.

Main duties of the job

The CRN will be involved in every stage of the portfolio activities including feasibility reviews of new clinical trial opportunities, set-up and activation of new trials, patient recruitment and management, supporting team with data query resolution, reviewing protocol amendments, providing patient-centred insights to the research delivery team by supporting both the patients and the team through all aspects of clinical research of the Breast portfolio.
With support from the team the CRN will ensure that the safety and wellbeing of the patients is maintained within the requirement of the multi-regulatory frameworks for clinical research ensuring compliance with ICH/GCP standards and Trust SOPs.
By utilising national frameworks for auditing patients experience the CRN will ensure the patients in the Breast disease portfolio studies will have the best possible experience whilst participating in clinical research.
Raise the profile of the clinical research nurse and clinical trials within the trust by engaging in promotional events relating to clinical research with attendance and contributions at local, national and international meetings.
Demonstrate awareness and contribution to divisional, Trust and national objectives and strategies.

Working for our organisation

The Christie is one of Europe’s leading cancer centres, looking after more than 64,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 25% patients are referred to us from other parts of the country.

We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.

We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK’s National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.

Detailed job description and main responsibilities

Clinical Research Co-ordination

• Work autonomously in all areas of practice relating to clinical research.
• Understand and deliver care in accordance with regulatory approved clinical research protocols.
• Understand the process for obtaining NHS permissions (R&D approval) for conducting clinical trials at site. As project lead, ensure permissions are in place prior to any patient recruitment.
• Participate in clinical trial feasibilities and risk assessments of clinical trial protocols.
• Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.
• Awareness of trial specific, regional and national targets. Identify and implement strategies for recruiting patients to clinical trials ensuring that targets for patient recruitment are delivered.
• Delegation and oversight of research related activities to research team members (clinical and administrative) and ensure compliance with SOPs and ICH/GCP.
• Arrange and facilitate clinical trial related meetings.
• Involvement in appropriate financial remunerations for clinical trial activity.

Clinical Service and Professional Responsibilities

• Assimilation of highly complex information relating to clinical trials and communication to patients at a level appropriate to their understanding. Ensure highly sensitive information is communicated to patients, relatives, and carers regarding prognosis
• Contribute to the development, implementation, and review of specialist care pathways in conjunction with appropriate personnel.
• Demonstration of expert knowledge in specialist area to maintain clinical excellence.
• Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.
• Escalation of governance issues impacting on delivery of job purpose.
• To act as a primary contact point for the clinical trial patients and act as adviser to other healthcare professionals.
• Responsibility for maintenance and development of professional knowledge and practice by attending mandatory and specialist training in accordance with local policy.
• Ensuring care delivery standards in accordance with trial protocol, local policy, NMC Code of Practice Conduct and current best practice.
• Development and maintenance of a high-quality service by:
• Overseeing the safe administration of all licensed and unlicensed medicinal products within the context of a clinical trial.
• Overseeing assessment and evaluation of treatment toxicities and initiation of appropriate intervention.
• Contribute to development of specialist Standard Operating Procedures and guidelines.
• Provide education and support for non-research staff in the delivery of protocol driven treatment for all patients.
• Participate in monitoring and audit activities within research team
• To carry out non-medical prescribing within scope of professional practice and in accordance with local policies and procedures and national legislation (optional and depending on clinical service needs).

Personal Education, Training and Development

• Maintain professional development whilst evaluating own specialist knowledge and practice through a process of appraisal and personal development planning.
• Promote the role of the clinical research nurse as an integral part of the healthcare system.
• Increase and maintain awareness of current advances in cancer treatments, research and nursing practice thereby maintaining the highest standard of care for patients with cancer and implementing evidence-based care by continuing professional development.
• Participation in trust-wide education programmes and study days.
• Obtain clinical supervision as appropriate.
• To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
• Attendance at team and divisional meeting

Staff Management and Development

• To Support the Senior Clinical Research Nurse in the induction and continued supervision of junior members of staff, ensuring compliance with regulatory compliance and legislation.
• Support the development of specialist study days within own research team.
• Assist in the provision of specialist education and training in relation to clinical trials to all key stakeholders.
• Disseminate information by attendance and /or presentations at local, national and international conferences/meetings
• Contribute to the development of members of the research team

______________________________________________________________________________
EU DIRECTIVE ICH/GCP
All personnel involved in clinical research have a responsibility to ensure that clinical trials are conducted in accordance with the EU Directive and ICH/GCP.

Qualifications

• Registered General Nurse -Currently registered with the Nursing & Midwifery Council
• First Degree or relevant clinical experience
• Post-graduate qualification in oncology and/or clinical research
• GCP/ICH recognised recent training

Experience

• Experience of Oncology Nursing
• Experience of working autonomously and as part of a Multi-disciplinary team
• Ability to demonstrate evidence of service improvement
• Experience of working in a clinical research environment

Skills

• Highly effective communication skills
• Advance organisational skills
• Good written and analytical skills
• Able to manage work autonomously and manage own workload
• Demonstrable IT Skills – able to use Word, PowerPoint, Excel and Outlook
• Intra-venous access and cannulation skills administration of IV chemotherapy

Knowledge

• Knowledge of the clinical trial process
• Knowledge of ICH-GCP & research governance framework
• Knowledge of professional and NHS issues and policy relating to specialist area
• Knowledge of Research Ethics Committees
• Knowledge of the purpose of clinical research

Values

• Ability to demonstrate the organisational values and behaviours

Other

• Maintain professional development and have an awareness of current nursing issues
• Demonstrates flexibility in working hours

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Sponsorship Information -We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications.Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on the government website.

Pre-Employment Checks -To confirm your suitability for the role, we will carry out pre-employment checks in line with NHS Employment Check Standards. These include:

• Identity verification
• Right to work check
• Disclosure and barring service (DBS)/Criminal record check (dependent on role, payment of this will be the applicants responsibility)
• Professional registration and/or qualification check
• Occupational health assessment
• Employment history and reference validation

All applicants external to The Christie NHS Foundation Trust will be required to provide their HMRC employment history to cover the most recent three years employment. This information will used to validate employment history andreferences.

If you require sponsorship, we will assess your eligibility based on current government guidance. If the role is not eligible and you cannot demonstrate your right to work, your conditional offer may be withdrawn.

If You're Offered the Role - you will be agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

No Smoking Policy - You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Additional Information - We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect.The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

The Christie NHS Foundation Trust is committed to the highest standards of ethical conduct and integrity in all our activities. We have a zero-tolerance approach to modern slavery in any of its forms, including slavery, servitude, forced or compulsory labour, and human trafficking. We are fully committed to acting ethically and with transparency in all our business dealings and relationships, and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our organisation or supply chains.

Employer certification / accreditation badges

You must have appropriate UK professional registration.

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.