About this role
Job summary
This is an exciting opportunity for a highly motivated Research Nurse to join the Advanced Immune and Cell Therapy (AICT) Research Team. The AICT team is an early phase clinical trials team specialising in the delivery of cell therapy studies and complex immunotherapy trials across a range of solid cancer types. The team strives to deliver the next generation of innovative cancer treatments for solid tumors. Examples of our cell therapy studies include CAR-T, TIL and TCR trials.The band 7 Clinical Research Nurse is expected to provide leadership of the AICT Research team and manage a varied and growing portfolio of early phase oncology studies.Central to this role is the responsibility of assessing and managing the care pathways including the delivery of all specified treatments for participants in research within a multidisciplinary team. Key responsibilities of the post include the co-ordination of the cell therapy and complex immunotherapy trial protocols and providing support for early phase solid tumour trial patients.The Band 7 Clinical Research Nurse will use their role to enhance the team's ability and capacity to undertake high quality clinical research by developing knowledge, skills, and practice within the team.A background in research and oncology, flexibility in working, excellent communication and interpersonal skills are essential.
Main duties of the job
The Band 7 Clinical Research Nurse 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 AICT portfolio.With support from the team the Band 7 Clinical Research Nurse 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.They will provide support, induction, continued supervision and management of the AICT research team and Demonstrate awareness and contribution to divisional, Trust and national objectives and strategies.By utilising national frameworks for auditing patients experience the Band 7 Clinical Research Nurse will ensure the patients participating in AICT portfolio studies will have the best possible experience whilst participating in clinical research.They will 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.
About us
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.
Job description Job 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. Oversee the process for obtaining NHS permissions (R&D approval) for clinical trials within team. As project lead, ensures permissions are in place prior to any patient recruitment. Undertake feasibility and risk assessments of clinical trial protocols in conjunction with Team Leader, Principal Investigator and Senior Clinical Trials Co-Ordinator Ensure all clinical trial activities are recorded in appropriate systems in a timely manner. Awareness of trial specific, regional, and national targets. Initiate new recruitment strategies for recruiting patients to clinical trials including engagement with the research network. In conjunction with Team Leader lead on the delegation of all trial related activities to research team members (clinical and administrative) and ensure compliance with SOPs and ICH/GCP. Work with team leader and sponsor companies in the preparation and negotiation of financial contracts for individual trials. Arrange and facilitate clinical trial related meetings. In conjunction with Team Leader, oversee 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 careers regarding prognosis Responsible for 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. Set up processes/patient pathways in conjunction with appropriate personnel from specialist research areas to promote a cost-effective timely service for individual protocols (shared care pathways, specialist clinics, etc.). Support Team Leader in delivering 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 health care professionals. Responsibility for maintenance and development of professional knowledge and practice by attending mandatory and specialist training (e.g., GCP) 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:o Overseeing the safe administration of all licensed and unlicensed medicinal products within the context of a clinical trial.o Overseeing assessment and evaluation of treatment toxicities and initiation of appropriate intervention.o 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 programs 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 meetings.
Staff Management and Development In conjunction with the team leader, provide the induction, continued supervision and management of the research teams. In conjunction with the team leader, be responsible for ensuring all members of the research nurse team undergo regular appraisal and support appropriate training and development opportunities in line with role requirements. Lead on the development of specialist study days within own research team Provide 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 Be responsible for the development of members of the research team.
EU DIRECTIVE ICH/GCPAll personnel involved in clinical research have a responsibility to ensure that clinical trials are conducted in accordance with the EU Directive and ICH/GCP.
Person Specification
Qualifications Essential
Registered General Nurse -Currently registered with the Nursing & Midwifery Council First Degree or relevant experience GCP/ICH recognised recent training
Desirable
Post-graduate qualification in oncology and/or clinical research
Experience Essential
Relevant oncology nursing experience Clinical research experience or other relevant experience related to specialism Experience in coordinating clinical trials from initiation to closure including archiving Proven evidence of service improvement Experience of working autonomously and part of a multi-disciplinary team Ability to organise and prioritise own workload
Desirable
Experience of managing Clinical Research Teams Experience of clinical audits both internal and external Experience of writing standards operating procedures for clinical research and individual protocols
Skills Essential
Highly effective communication skills Effective team working across professional and organisational boundaries Good written and analytical skills Involvement in informed consent process within scope of professional practice Co-ordinates care pathway for patients and carers participating in clinical research Manages, assesses and supports the physical and psychological needs of the patient and carer Able to manage work autonomously Training and leadership skills Demonstrable IT Skills able to use Word, PowerPoint, Excel and Outlook
Desirable
Intra-venous access and cannulation skills administration of clinical trial therapies Good presentation skills
Knowledge Essential
Has a working and intellectual knowledge of the purpose of clinical research Has specialist knowledge of Research Ethics Committees and has been actively involved in the process of gaining relevant clinical trial approval and is able to guide members of the research team through the approval process Knowledge of professional and NHS issues and policy relating to specialist area Maintain Professional development and have an awareness of current nursing issues
Desirable
Knowledge of Research Ethics Committees Knowledge of the purpose of clinical research
Values Essential
Ability to demonstrate the organisational values and behaviours
Other Essential
Maintain professional development and have an awareness of current nursing issues Demonstrates flexibility in working hours
Desirable
Assertiveness
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.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).
Employer details Employer name The Christie NHS FT
Address AICT - Q02054
Manchester
M20 4BX
United Kingdom
Employer's website https://www.christie.nhs.uk/ (Opens in a new tab)