Job Description

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.



The post holder will be responsible for the co-ordination of a defined group of clinical trials from

set up to archiving and meeting agreed patient recruitment targets.

The post holder will also:

Ensure that all research undertaken within the department safeguards the well being

of the patients

Ensure that research is conducted within requirements of a multi-regulated clinical

research environment.

Facilitate the production of high-quality research. Raise the profile of the clinical research nurse and clinical trials Demonstrate awareness and contribution to divisional, Trust and national objectives.

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.

DUTIES AND RESPONSIBILITIES:

Work autonomously in all areas of practice relating to clinical research. Understand and deliver care in accordance with regulatory approved clinical research

protocols.

Clinical Research Nurse Band 6 - 2 - Updated 26/07/24

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

health care 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).

Clinical Research Nurse Band 6 - 3 - Updated 26/07/24

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