Job Description
Job summary The post of Senior Clinical Research Nurse for the Haematology Research Team presents an exciting opportunity to join an established and successful research team with a varied and growing portfolio of haematological malignancies. The team supports a large number of industry-led, non-commercial and academic led trials from early to later phase studies. We are seeking an enthusiastic and highly motivated individual who will be responsible for the management of a team of clinical research nurses and the co-ordination of a defined group of clinical trials, from set up to archiving. The post holder will work collaboratively alongside the team of Consultants, Clinical Fellows, Research Nurses, Clinical Trial Pharmacists and Clinical Trial Coordinators. This is a new developing role within a group of existing senior clinical research nurses in the team, supported through the R&I division with a good education and development package in place to ensure that staff reach their potential. A background in oncology and research, flexibility in working, excellent communication and interpersonal skills are essential. Experience in haematology and leadership/management would be desirable. An informal discussion about the post is strongly recommended with the possibility to spend some time with the team to understand better the requirement of the role. Main duties of the job Key responsibilities of the post include leadership and management of a group of haematology clinical research nurses (supporting the Research Nurse Team Leader), ensuring research is conducted within requirements of a multiregulated clinical research environment safeguarding the wellbeing of patients. You will interact with variety of research professionals across The Christie, including the NIHR Manchester Clinical Research Facility; as well as commercial partners, other NHS Institutions, Research bodies and wider community. You should have a proactive approach to self-development as well as being able to demonstrate initiative and expertise in team development and training programmes. Also, by utilising national frameworks for auditing patients experience, you will ensure the patients in the Haematology disease portfolio studies will have the best possible experience whilst participating in clinical research. Other responsibilities are raising the profile of the clinical research nurse and clinical trials, within the Trust and externally; engaging in promotional events related to clinical research; and contributing to divisional, Trust and national objectives and strategies. About us The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK. Job description 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 (, 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. Person Specification 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 at Band 6 or 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. Other Essential Maintain professional development and have an awareness of current nursing issues. Demonstrates flexibility in working hours Desirable Assertiveness Values Essential Ability to demonstrate the organisational values and behaviours