Senior Clinical Research Nurse

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Detailed job description and main 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, Principle 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 carers 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:
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 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/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.

Person specification

Qualifications

Essential criteria

• First Level Registration
• First Degree or equivalent experience
• Post Registration oncology qualification or equivalent experience
• Teaching and Assessing
• GCP/ICH recognised recent training

Desirable criteria

• Masters Degree

Experience

Essential criteria

• Experience of working autonomously and as part of a Multi-disciplinary team.
• Relevant oncology nursing experience
• Clinical research experience at Band 6 or other relevant experience related to specialism.
• Experience in co-ordinating clinical trials from initiation to closure including archiving.
• Experience of working autonomously and part of a multi-disciplinary team. Ability to organise and prioritise own workload.

Desirable criteria

• Experience of working in a clinical research environment.
• 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 criteria

• 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 criteria

• Intra-venous access and cannulation skills
• Administration of clinical trial therapies.
• Good presentation skills.

Knowledge

Essential criteria

• Knowledge of the clinical trial process
• Knowledge of ICH-GCP
• Knowledge of research governance framework
• Knowledge of professional and NHS issues and policy relating to specialist area.
• 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 ethical 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 criteria

• Knowledge of Research Ethics Committees
• Knowledge of the purpose of clinical research.

Other

Essential criteria

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

Desirable criteria

• Assertiveness

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.

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

All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.

By applying for this post you are 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.

If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

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.

Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.

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

Employer certification / accreditation badges

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Job Description and Person Specification (PDF, 176.4KB)
• The Christie Values and Behaviours (PDF, 919.5KB)
• Strategy Brochure (PDF, 1.0MB)
• Trust Membership - Christie Talent (PDF, 23.0KB)
• Travel to The Christie (PDF, 3.8MB)