Job summary
The post of Senior Clinical Research Nurse for CAR-T cell trials (Haematology and Lymphoma) presents an exciting opportunity to join two established and successful research teams with a varied and expanding portfolio of CAR-T cell clinical trials. The teams also support a large number of industry-led, non-commercial and academic-led trials, ranging from early to late-phase studies.
We are seeking an enthusiastic and highly motivated individual who will be responsible for the management and coordination of CAR-T cell clinical research studies, from set-up through to archiving, within haematology and lymphoma. This is a newly developing role within an established group of clinical research nurses.
The post holder will work collaboratively with Consultants, Clinical Fellows, Research Nurses, Clinical Trial Pharmacists and Cell Laboratory staff, Clinical Trial Coordinators and other supporting service departments involved in CAR-T cell therapy. In addition, the role includes line management responsibilities and participation in the senior research teams within haematology and lymphoma research.
Main duties of the job
Key responsibilities of the post include the management and coordination of CAR-T cell clinical trials in haematology and lymphoma, ensuring that research is conducted in accordance with the requirements of a multi-regulated clinical research environment and that patient safety and wellbeing are safeguarded. The role also includes leadership and management responsibilities, supporting the Clinical Research Matron.You will interact with a wide range of research professionals, haematology and lymphoma specialists and staff across The Christie, as well as commercial partners, other NHS institutions, research bodies and the wider community. A proactive approach to professional development is essential, alongside the ability to demonstrate expertise in CAR-T cell therapy, initiative for team development and training programmes.In addition, by utilising national frameworks to audit patient experience, you will ensure that participants in CAR-T cell portfolio studies receive the best possible experience while taking part in clinical research. Further responsibilities include raising the profile of the clinical research nurse role and CAR-T cell clinical trials both within the Trust and externally, engaging in promotional events related to clinical research and contributing to divisional, Trust-wide and national objectives and strategies.
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
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.
OTHER
A background in haemato-oncology, particularly CAR-T cell therapy, and clinical research is essential, along with flexibility, and excellent communication and interpersonal skills. Experience in leadership and management is desirable. An informal discussion about the post is strongly encouraged, with the opportunity to spend time with the team to gain a better understanding of the role and its requirements.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.
Job description
Job responsibilities
DUTIES AND 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.
OTHER
A background in haemato-oncology, particularly CAR-T cell therapy, and clinical research is essential, along with flexibility, and excellent communication and interpersonal skills. Experience in leadership and management is desirable. An informal discussion about the post is strongly encouraged, with the opportunity to spend time with the team to gain a better understanding of the role and its requirements.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 at Band 6 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
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 at Band 6 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
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).
