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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:

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 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.

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.