NursingNetUK

Swydd ddisgrifiad a phrif gyfrifoldebau manwl

JOB PURPOSE

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.

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.
• 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:

1. Overseeing the safe administration of all licensed and unlicensed medicinal products within the context of a clinical trial.
2. Overseeing assessment and evaluation of treatment toxicities and initiation of appropriate intervention.
3. 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 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

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.