Job summary
This post presents an exciting opportunity to join the Advanced Immune and Cell Therapy (AICT) Research Team as a Clinical Research Nurse. 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.
Research nursing is an exciting and developing role, supported through the Research & Innovation (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 co-ordination of the cell therapy and complex immunotherapy trial protocols and providing support for early phase solid tumour trial patients.
A background in oncology, flexibility in working, excellent communication and interpersonal skills are essential. Experience in clinical research and/or haematology transplant/cell therapy would be desirable, but not essential.
An informal conversation to discuss the post is strongly recommended.
Main duties of the job
The post holder will be responsible for the co-ordination of a defined group of clinical trials fromset up to archiving and meeting agreed patient recruitment targets.The post holder will also:o Ensure that all research undertaken within the department safeguards the well beingof the patientso Ensure that research is conducted within requirements of a multi-regulated clinicalresearch environment.o Facilitate the production of high-quality research.o Raise the profile of the clinical research nurse and clinical trialso Demonstrate awareness and contribution to divisional, Trust and national objectives.
About us
The Christie is one of Europe's leading cancer centres, treating over 60,000 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 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES:
Work autonomously in all areas of practice relating to clinical research. Understand and deliver care in accordance with regulatory approved clinical researchprotocols.Clinical Research Nurse Band 6 - 2 - Updated 26/07/24 Understand the process for obtaining NHS permissions (R&D approval) for conductingclinical trials at site. As project lead, ensure permissions are in place prior to any patientrecruitment. 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 strategiesfor recruiting patients to clinical trials ensuring that targets for patient recruitment aredelivered. Delegation and oversight of research related activities to research team members (clinicaland 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 topatients at a level appropriate to their understanding. Ensure highly sensitive informationis communicated to patients, relatives, and carers regarding prognosis Contribute to the development, implementation, and review of specialist care pathways inconjunction with appropriate personnel. Demonstration of expert knowledge in specialist area to maintain clinical excellence. Demonstrate awareness of divisional and trust strategic objectives including performanceindicators 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 otherhealth care professionals. Responsibility for maintenance and development of professional knowledge and practiceby attending mandatory and specialist training in accordance with local policy. Ensuring care delivery standards in accordance with trial protocol, local policy, NMC Codeof Practice Conduct and current best practice. Development and maintenance of a high-quality service by: Overseeing the safe administration of all licensed and unlicensed medicinalproducts within the context of a clinical trial. Overseeing assessment and evaluation of treatment toxicities and initiation ofappropriate intervention. Contribute to development of specialist Standard Operating Procedures andguidelines. Provide education and support for non-research staff in the delivery of protocol driventreatment for all patients. Participate in monitoring and audit activities within research team To carry out non-medical prescribing within scope of professional practice and inaccordance with local policies and procedures and national legislation (optional anddepending on clinical service needs).Clinical Research Nurse Band 6 - 3 - Updated 26/07/24Personal Education, Training and Development Maintain professional development whilst evaluating own specialist knowledge andpractice through a process of appraisal and personal development planning. Promote the role of the clinical research nurse as an integral part of the healthcaresystem. Increase and maintain awareness of current advances in cancer treatments, research andnursing practice thereby maintaining the highest standard of care for patients with cancerand 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 themanagement of clinical research ensuring timely, effective implementation of changes. Attendance at team and divisional meetingStaff Management and Development To Support the Senior Clinical Research Nurse in the induction and continued supervisionof junior members of staff, ensuring compliance with regulatory compliance andlegislation. 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 allkey stakeholders. Disseminate information by attendance and /or presentations at local, national andinternational conferences/meetings Contribute to the development of members of the research team
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES:
Work autonomously in all areas of practice relating to clinical research. Understand and deliver care in accordance with regulatory approved clinical researchprotocols.Clinical Research Nurse Band 6 - 2 - Updated 26/07/24 Understand the process for obtaining NHS permissions (R&D approval) for conductingclinical trials at site. As project lead, ensure permissions are in place prior to any patientrecruitment. 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 strategiesfor recruiting patients to clinical trials ensuring that targets for patient recruitment aredelivered. Delegation and oversight of research related activities to research team members (clinicaland 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 topatients at a level appropriate to their understanding. Ensure highly sensitive informationis communicated to patients, relatives, and carers regarding prognosis Contribute to the development, implementation, and review of specialist care pathways inconjunction with appropriate personnel. Demonstration of expert knowledge in specialist area to maintain clinical excellence. Demonstrate awareness of divisional and trust strategic objectives including performanceindicators 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 otherhealth care professionals. Responsibility for maintenance and development of professional knowledge and practiceby attending mandatory and specialist training in accordance with local policy. Ensuring care delivery standards in accordance with trial protocol, local policy, NMC Codeof Practice Conduct and current best practice. Development and maintenance of a high-quality service by: Overseeing the safe administration of all licensed and unlicensed medicinalproducts within the context of a clinical trial. Overseeing assessment and evaluation of treatment toxicities and initiation ofappropriate intervention. Contribute to development of specialist Standard Operating Procedures andguidelines. Provide education and support for non-research staff in the delivery of protocol driventreatment for all patients. Participate in monitoring and audit activities within research team To carry out non-medical prescribing within scope of professional practice and inaccordance with local policies and procedures and national legislation (optional anddepending on clinical service needs).Clinical Research Nurse Band 6 - 3 - Updated 26/07/24Personal Education, Training and Development Maintain professional development whilst evaluating own specialist knowledge andpractice through a process of appraisal and personal development planning. Promote the role of the clinical research nurse as an integral part of the healthcaresystem. Increase and maintain awareness of current advances in cancer treatments, research andnursing practice thereby maintaining the highest standard of care for patients with cancerand 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 themanagement of clinical research ensuring timely, effective implementation of changes. Attendance at team and divisional meetingStaff Management and Development To Support the Senior Clinical Research Nurse in the induction and continued supervisionof junior members of staff, ensuring compliance with regulatory compliance andlegislation. 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 allkey stakeholders. Disseminate information by attendance and /or presentations at local, national andinternational conferences/meetings Contribute to the development of members of the research team
Person Specification
Qualifications
Essential
- Registered General Nurse -Currently registered with the Nursing & Midwifery Council
- First Degree or relevant clinical experience
Desirable
- Post-graduate qualification in oncology and/or clinical research
- GCP/ICH recognised recent training
Experience
Essential
- Experience of oncology nursing.
- Experience of working autonomously and as part of a Multi-disciplinary team.
- Ability to demonstrate evidence of service improvement
Desirable
- Experience of working in a clinical research environment.
Skills
Essential
- 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
Desirable
- Intra-venous access and cannulation skills administration of IV chemotherapy.
- Good presentation skills.
Knowledge
Essential
- 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.
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
Person Specification
Qualifications
Essential
- Registered General Nurse -Currently registered with the Nursing & Midwifery Council
- First Degree or relevant clinical experience
Desirable
- Post-graduate qualification in oncology and/or clinical research
- GCP/ICH recognised recent training
Experience
Essential
- Experience of oncology nursing.
- Experience of working autonomously and as part of a Multi-disciplinary team.
- Ability to demonstrate evidence of service improvement
Desirable
- Experience of working in a clinical research environment.
Skills
Essential
- 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
Desirable
- Intra-venous access and cannulation skills administration of IV chemotherapy.
- Good presentation skills.
Knowledge
Essential
- 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.
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
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.
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).
Additional information
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.
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).
