Clinical Trial Research Nurse Lead for Cancer and Surgery

Do you have an interest in research?

Mid Cheshire Hospitals NHS Foundation Trust is pleased to offer an exciting opportunity for an enthusiastic senior registered nurse to join our Surgery and Cancer Research team in this Band 7 post.

A nursing background in Surgery/Cancer or Research is essential with at least 4 years at Band 6 level. The CTRN Lead will provide strategic, management and research support for clinical trials in Cancer & Surgery Division. As the CTRN Lead you will contribute to all aspects of the planning, conduct and reporting of all clinical trial activities and in-house studies in the relevant specialty.

Successful candidates will coordinate the delivery of high quality research across several specialities such as Breast, Prostate, Bowel cancers, Orthopaedics and Surgical interventions

Continued training and education are essential within this role and we have a strong commitment to the growth and development of the individuals within the team. The post holder will be responsible for assessing and managing the care pathways for patients and carers participating in clinical trials. This will involve the recruitment, education and monitoring of cancer patients in trials and the collection and documentation of accurate data.

NMC registration is essential for this post.

Informal visits are welcomed and provide an opportunity to meet the team and find out more about the role.

Main duties of the job The successful candidate will lead the Surgery and Cancer Research Team in conducting a varied portfolio of research projects by performing 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

To conduct and set up clinical trials according to protocol, to obtain informed consent for research trials, and ensuring that the objectives of the research team are met in accordance with ICH-GCP standards.

You will work collaboratively with local R& D members to assess capacity and capability for research studies as well as working with other members of the research teams to inform potential participants of appropriate projects. You will manage a team of staff including nursing members and administrative roles and act as a role model by being supportive and encouraging development. You will attend meetings at board level to promote research and to inform of relevant information and trials.

The duties will also include reporting to North West Coast Clinical Research Network and supporting study recruitments managed by the Network. Training will be provided for a successful candidate new to research/ Surgery/Cancer however all candidates are required to familiarise themselves with ICH-GCP standards.

You will be conversant with UK Policy Framework for Health and Social Care and ICH - GCP. About us Mid Cheshire Hospitals NHS Foundation Trust (MCHFT) provides good quality, safe and effective healthcare to the people of Cheshire and beyond. The Trust, which manages Leighton Hospital in Crewe, Victoria Infirmary in Northwich, and Elmhurst Intermediate Care Centre in Winsford, was established as an NHS Trust in April 1991 and became a Foundation Trust in April 2008.

We employ almost 5,000 members of staff, provide around 540 hospital beds, with a range of services including accident and emergency, maternity, outpatients, therapies, and children's health.

The Trust is also part of Central Cheshire Integrated Care Partnership (CCICP), a unique local health partnership that provides a range of community services for people across South Cheshire and Vale Royal.

During the Coronavirus pandemic, the Trust was recognised nationally for its 'Be Safe Be EquiPPEd' campaign, which aimed to make the Trust as safe as possible for staff and patients, through supporting the correct use of PPE. The results in the 2020 national NHS Staff Survey showed improvements in all elements of the safety culture theme, with 92% of respondents feeling their role made a difference to our patients. We were also recognised nationally for our workforce health and wellbeing initiatives.

At Mid Cheshire, we value our staff and appreciate that in order to give our patients the best quality, compassionate care, we also need to look after our colleagues. Job description Job responsibilities The Senior Research Nurse will be lead the Surgery and Cancer Clinical Trial Team and will be responsible for identifying new clinical trials, the set up of trials, creating patient pathways, coordinating clinical trial activities and lead the relevant trial recruitments.

The Senior Research Nurse 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.

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.

Attend multi-disciplinary meetings, and appropriate clinics, to screen and recruit new participants, and to act as a resource to the members of the multi-disciplinary team (MDT),

Ensure the safe administration of treatments and the drugs that are given within the context of a clinical trial.

Management of staff members and leadership

Ensure that trial specific investigations are undertaken as required by the trial protocol, in order to establish eligibility and safety to enter the trial

Attend and present at regular meetings at board level and maintain research visibility throughout the trust and external service providers

Attend away days with teams and contribute with promotion of research

Provide ongoing information, education and support to study subjects, carers and families regarding clinical trials

Perform clinical skills in assessment, ensure blood and other samples are collected for pharmacokinetic studies as required by the trial protocol, diagnosis and treatment by working collaboratively and co-operatively with the clinical team, and by involving the patient, carers / relatives in the care provided,

Carry out clinical procedures and treatment interventions according to study protocols, and collection, processing and transporting of biological specimens as required by the protocols.

• 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 PIs, 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 MDTs 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.
• Perform meetings with staff members quarterly for appraisals
• 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 m
  Any attachments will be accessible after you click to apply. 412-CORP.70152

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