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Detailed job description and main responsibilities

The Research Nurse (RN) will be part of the Surgery and Cancer Clinical Trial Team and will be responsible for coordinating clinical trial activities and lead the relevant trial recruitments. 

The RN will perform a range of clinical trial activities from obtaining legal and statutory approvals for clinical trials, setting up trials, as well as handling and managing trial recruitments and data.  

• Provide a comprehensive clinical trial support to the local Principal Investigators (PIs) working on the research portfolio of the National Institute of Health Research (NIHR) and non-portfolio studies.
• Initiate the process for local Research and Development  confirmation of Capacity and Capability of clinical trial projects.
• Proactively manage and maintain the dialogue between PI’s, clinical trial support (pharmacy, radiology and pathology) and Trial Coordinating Centres, by liaising with relevant groups ensuring that all the required preparation is accurate and available, and that the senior management team and other relevant parties are briefed on any difficulties, problems or issues.
• Assist in the review of trial protocols and identify resource implications for the site. Liaise with and seek specialist input as appropriate i.e. Clinicians / treatment units / specialist nurses / pharmacy / radiology / pathology etc.
• Ensure that MDT’s are aware of the current trials portfolio by integrating trials into current clinical practice.
• Perform a comprehensive, specialist assessment of patient eligibility for specific trial protocols. Plan, implement and evaluate care delivery for own case load, according to changing health care needs, and in conjunction with the clinical team.
• Assist the Lead Clinician and PI in the process of informed consent and obtain informed consent for delegated studies.
• Perform clinical skills in assessment, diagnosis and treatment by working collaboratively and co-operatively with the clinical team, and by involving the patient, carers / relatives in the care provided.
• Disseminate clinical evidence, advice and guidance as a result of participating in clinical trial research.
• Contribute to the development of policies, standard operating procedures and clinical guidelines for implementation within and across clinical teams, including negotiating the application of best practice within relevant external agencies.
• Identify strategies for recruiting patients to clinical trials.
• Ensure that clinical trial protocols are adhered to.
• Ensure that you and the team are working according to GCP and research governance standards for clinical trials.
• Facilitate the informed consent process ensuring the following is accounted for: -
  • The patient (and significant others) fully understands the nature of the clinical trial,
  • The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice,
  • The patient is aware of any extra procedures required by the trial,
  • The consent form is completed accurately and filed as required
• Register and randomise patients’ entry into trials.
• Responsible for forwarding trial data in a timely manner to the trial coordinating centre.
• Supply data as required to the Network Research Manager regarding progress of clinical trials.
• Identify barriers to recruitment to trials and ensure that the Research Network Manager is aware of them.  Identify and implement/support action plans as required
  • Assist with the management of clinical trials at MCHFT as determined by the Surgery and Cancer Research Team Lead and R&D Manager
• Provide support for clinical trial colleagues in their absence.
• Review of trial related documents and undertaking risk assessment with clinical trials team, in preparation for internal audit and report.
• Liaise with Pharmacovigilance coordinator to make sure prompt processing and reporting of serious adverse events according to regulatory guidelines.
• In the event of a statutory inspection, contribute to and participate in the preparation for the inspection, including contributing to the project dossier.
• To conduct all activities in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004, UK Policy Framework for Health and Social Care Research, ICH Good Clinical Practice (ICH GCP) guidelines, Data Protection Act and other local policies and procedures.
• To develop and maintain systems and processes to establish and continue effective communication and confidentiality of information.
• To support the development and maintenance of systems and processes to continually monitor standards, e.g. benchmarking, audit, and implement action plans to improve the quality of clinical trial services.
• To support R&D to ensure that lessons are learnt from issues arising from risk reports or complaints etc, and to verify that they are promptly and positively addressed.
• To contribute to the development, updating and implementation of policies, standard operation procedures and guidelines related to services, and to contribute to the development of other policies as required.
• To promote and update staff knowledge and skills on the Medicines for Human Use (Clinical Trials) Regulations 2004, UK Policy Framework for Health and Social Care Research, ICH Good Clinical Practice (ICH GCP) guidelines, Data Protection Act and other local policies and procedures.
• Maintain awareness of current advances in relevant treatments, research and nursing practice and use this knowledge to maintain high standards of care for all trial patients.
• Ensure compliance with Trust policies, procedures and guidelines for self and others, by taking action/alerting senior management team if practice appears to contravene policy, or if concerned about any aspect of patient care. 
• Act as a role model by demonstrating leadership and expertise, and by maintaining credibility within the Department, the wider health care community and external agencies, ensuring a positive image of the Trust is maintained.
• Support the Clinical Trial Services by participating in recruitment, and ensuring that staff induction and orientation, and mandatory training take place according to Trust policy.
• Supervise junior staff ensuring that work is appropriately prioritised and managed, providing support, advice and guidance to help others to learn and develop in their role.
• Develop and maintain systems and processes to promote monitor and maintain a healthy, safe and secure working environment, ensuring compliance with legal and regulatory requirements, maintaining accurate documentation and reporting any concerns.
• Work within trial specific protocols to ensure safe storage and transferring of specimens according to protocols, safe administration of trial drugs, to be aware of and appropriately report, side effects.
• Provide information to allow for invoices relating to trials to be raised for payments where appropriate.
• Attend meetings relevant to the nature of the job and contribute to effective general management.
• Promote and ensure effective communication across the Trust and within the clinical trial research community.
• Ensure a healthy, safe and secure working environment, ensuring compliance with legal and regulatory requirements, maintaining accurate documentation and reporting any concerns.

EDUCATION/LEARNING

• Take responsibility for own learning and development by recognising and taking advantage of all opportunities to learn, including full participation in KSF/appraisal, supervision, action learning and by maintaining a professional/personal portfolio of learning.
• Provide expert advice and work-based training from a sound knowledge base to junior staff, evaluating the impact of learning on improving services.
• In conjunction with the Divisional Management Team, develop and maintain systems and processes to ensure that learning needs are identified and met, and that all learning is planned, implemented, evaluated and shared in order to change and improve services according to changing health care needs.
• Maintain an awareness of changes in governance requirements.
• Maintain links with other trial coordinators, data managers and research nurses across the region and also nationally to develop and share knowledge and to provide mutual support.