- 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, Principle 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 SOPsand ICH/GCP.
- Work with team leader and sponsor companies in the preparation and negotiation offinancial contracts for individual trials.
- Arrange and facilitate clinical trial related meetings.
- In conjunction with Team Leader, oversee appropriate financial remunerations for clinical trial activit
- Assimilation of highly complex information relating to clinical trials and communication to patients at a level appropriate to their understanding. Ensure highly sensitive informationis communicated to patients, relatives and carers 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 medicinalproducts within the context of a clinical Overseeing assessment and evaluation of treatment toxicities and initiation of appropriate 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).
- 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 cancerand 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 meetings.
- 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 anddevelopment 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.______________________________________________________________
- Registered General Nurse - Currently registered with the Nursing & Midwifery Council
- First Degree or relevant experience
- GCP/ICH recognised recent training
- Post-graduate qualification in oncology and/or clinical research
- Relevant oncology nursing experience
- Clinical research experience at Band 6 or other relevant experience related to specialism
- Experience in co-ordinating 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
- 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
- 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
- Intra-venous access and cannulation skills administration of clinical trial therapies
- Good presentation skills
- 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
- Knowledge of Research Ethics Committees
- Knowledge of the purpose of clinical research
- Maintain professional development and have an awareness of current nursing issues
- Demonstrates flexibility in working hours
- Assertiveness
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Senior Clinical Research Nurse - Manchester, United Kingdom - The Christie NHS FT
Description
Job summary
An exciting opportunity has arisen within the Research and Innovation Division at The Christie. We are looking to appoint a Senior Clinical Research Nurse to the Pan Tumour research delivery team within The Christie NHS Foundation Trust.
We are seeking an enthusiastic and highly motivated individual, who can demonstrate significant experience in supporting Pan Tumour cancer patients with their treatment and management in a multi professional team environment.
Experience of all aspects of clinical trial activity including supporting set up of new studies collaboration with data management and queries. We are looking for an individual with excellent organisation and communication skills, who can work well both in a team and using their own initiative. The individuals must demonstrate good leadership skills that will promote an environment of quality and learning.
The role is ideal for individuals to build upon line management and leadership experience in a clinical environment. It is tailored to equip the successful candidates with the necessary skills and experience to become a future leader in this field.
Applicants should meet all the essential criteria described in the job description as a minimum.
Main duties of the job
The focus of this role is to provide support to sustain and improve an excellent level of service provision for our patients. In order to support our growth as a centre of excellence in research training will be provided to the successful candidates to consolidate the skills required to provide management and leadership in the Pan Tumour Research Team.
The role will involve aspects of work allocation and support of clinical staff with direct line management, contribution to team metrics, set up of new trials and coordination of ongoing trials. Workload assignment will vary and not all aspects of the job description will be performed. Opportunities will be available to lead service development projects within the team and the wider R&I division.
The post holders will be expected to provide support to the senior R&I management and clinical research staff, and ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements
About us
The Pan TumourCancer Research Team vision is to build upon our reputation as a local and national leader in clinical trial delivery. Pursuing exemplary care and prioritising the safety and experience of our clinical research participants, carried out by a highly trained and passionate clinical research team.
By becoming a member of the Pan TumourCancer Research Team, you will be joining a dynamic and supportive team who are constantly striving to improve ourselves by working collaboratively across the nursing, medical and administrative teams.
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 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 descriptionJob responsibilities
DUTIES AND RESPONSIBILITIES:
Clinical Research Co-ordination
Clinical Service and Professional Responsibilities
Personal Education, Training and Development
Staff Management and Development
EU DIRECTIVE ICH/GCP All personnel involved in clinical research have a responsibility to ensure that clinical trialsare conducted in accordance with the EU Directive and ICH/GCP
Person SpecificationQualifications
Essential
Desirable
Experience
Essential
Desirable
Skills
Essential
Desirable
Knowledge
Essential
Desirable
OTHER
Essential
Desirable
