Senior Clinical Research Nurse

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.

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 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).