Bhsct Cancer Clinical Research Nurse Band 6

Advertised role location: ROYAL BELFAST HOSPITAL FOR SICK CHILDREN

Official document: Band 6_Cancer Clinical Research Nurse, NI Cancer Trials Centre (doc)

JOB DESCRIPTION

POST: Cancer Clinical Research Nurse

LOCATION: Northern Ireland Cancer Trials Centre Belfast City Hospital

BAND: 6

REPORTS TO: Lead Cancer Clinical Research Nurse/Network Manager

RESPONSIBLE TO: Lead Cancer Clinical Research Nurse/Network Manager

Job Summary / Main Purpose

Works unsupervised in day to day practice, in supporting the practice of cancer clinical research, co-ordinating a portfolio of cancer clinical trials and other high quality research studies. Working within the multi-professional team, is responsible for screening and recruitment, care, management and follow-up of a caseload of patients in clinical trials adhering to local and national regulatory, research and professional guidelines and policies.

Main Duties / Responsibilities

For each of the following, the postholder will;

Clinical Research

• Contribute to in-house protocol development stage on issues relating to patient and nursing activities, patient information, quality of life assessment and data collection.
• Review and present clinical research nursing perspective on new protocols, at cancer clinical trials study review and adoption meeting in relation to issues such as design, practicality, ethics, feasibility and patient selection.
• Attend Multidisciplinary Team Meetings and/or appropriate clinics or meetings to discuss trial eligibility and identify potential trial patients.
• Consent patients, as appropriate, in relation to nurse led protocols, procedures or clinical trials which have approval for Research Nurse consent and facilitates informed consent process for other clinical trials / therapies / procedures, according to guidelines and ethical and Good Clinical Practice (GCP) standards.
• Co-ordinate a portfolio of clinical trials as Primary Clinical Research Nurse, liaising closely with the Chief/Principal/Co Investigators, and Associate Clinical Research Nurse, throughout the duration of each study:
• Assist the Investigator in preparation of documentation for the research governance process and national Research Ethics Committee protocol approval, or site specific assessment.
• Liaise with clinical and department staff in preparation for study implementation.
• In multi-centre studies, liaise with the Clinical Research Associate (CRA) or Trial Co-ordinator as appropriate, and maintains on-going communication.
• Attend Investigator Meetings, as appropriate and contribute to national and international trial education and discussion.
• Develop schedules and checklists of protocol activities, screening, treatment, testing and data collection forms.
• Develop protocol specific 'study packs' to facilitate recruitment.
• Co-ordinate and participate in protocol initiation meetings.
• Provide education to nursing/medical staff regarding new protocols and updates as required, including amendments and findings.
• Contribute to meetings with in-patient / out-patient staff to discuss research issues arising and incoming study activity.
• Facilitate disease site-specific portfolio & trial review meetings with Investigators.
• Ensure adequate supplies of documents / equipment / laboratory supplies, for performance of the study.
• Identify and track potential trial patients when appropriate.
• Maintain screening logs and site records as required.
• Confirm patient eligibility and assists in scheduling screening investigations.
• Perform patient registration and randomisation procedures as appropriate.
• Update research databases such as EDGE.
• Ensure hospital records meet requirements for Case Report Form completion, and liaises with data managers regarding further data processing, delivery and storage.
• Ensure safe filing and storage of research related documentation.
• Ensure safe storage of blood, tissue or other biological samples, required for the research.
• Ensure maintenance of equipment required in research as appropriate.
• Co-ordinate Quality of Life assessment, and other symptom assessment aspects of the protocol as required.
• Monitor patient recruitment, and discuss recruitment problems / strategies with the investigators and provides feedback as appropriate during the Monthly Team Meeting.
• Collect / document treatment toxicity and notify appropriate internal and external bodies where serious adverse events or incidents arise.
• Devise a weekly appointment schedule for a case-load of patients including out-patient and Day Hospital attendances, in-patient admissions, community and GP visits and peripheral hospital protocol related attendances.
• Facilitate and review protocol compliance at all stages of the trial.
• Produce reports on patient profiles, trial recruitment and treatment toxicity as necessary.
• Comply with, and promote GCP and Research Governance Standards for clinical trials and maintains GCP training according to Clinical Trials legislation.
• Facilitate CRAs during monitoring meetings as required.
• Facilitate end-of study visits as required.
• Assist in audit and quality assurance procedures and meetings.
• Devise other operation or communication pathways, as required, for the effective co-ordination of the study, in liaison with the Lead Clinical Research Nurse/N. Ireland Cancer Trials Network Manager, NICTC team, and study investigator.
• Work in a team and act as Associate Clinical Research Nurse for a further portfolio of clinical trials, and provides cover for or assistance to other Clinical Research Nurses as required.

Clinical Practice / Patient Focused Care

• Plays a key role in informed consent process including:
• Provision of the current approved Patient Information Sheet.
• Explanation of study procedures, treatment and research terminology, in lay terms where possible.
• Explanation of the risks and benefits associated with participation in the clinical trial, including the treatment, procedures, time and any inconveniences involved.
• Involvement of the patient's family / carers as appropriate.
• Explanation of the patient’s rights in a research setting.
• Providing contact information to allow patients to ask questions and discuss options.
• Assess patient understanding and capability to consent. Liaise with the investigator and at all times act as patient advocate.
• Following written consent, assess patient's on-going wishes to continue participation in the study.
• Act as an on-going primary contact and resource for the patient throughout the duration of the study intervention, and follow-up, as appropriate. Provides easy access / contact for patients in clinical trials by telephone / bleep, and promotes regular communication.
• Educate patients regarding treatments and possible side-effects, facilitating treatment compliance, patient's understanding, and raising awareness of the patient's process for reporting side-effects and receiving medical care or advice as appropriate during the study.
• Assess the patient at each treatment visit and monitor side-effects, assessing appropriate steps to maximise patient safety and quality of life, and minimise toxicity. Monitors patient’s well-being by telephone as necessary.
• Monitor patient test results, liaise with Investigator or clinical team, as necessary.
• Assess patient care needs and refer and liaise with members of the multi-professional team as appropriate.
• Participate in administering protocol treatments or tests, when appropriate, and when competent to do so, if these activities are beyond the scope of the role of clinical staff in the Cancer Centre.
• Develop appropriate clinical, research or education, support and counselling skills as necessary within the role, to meet patient and family needs at all stages of the clinical research process and where the patient's condition / treatment / protocol / preference, or new evidence, indicates stopping study therapy is in the patient's best interest.
• Ensure appropriate blood / tissue / other biological samples are collected from patients as per patient consent and protocol schedule,

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