Swydd-ddisgrifiad a phrif gyfrifoldebau manwl

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:

➢ 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 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.