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Detailed job description and main responsibilities

Communication

To provide information and support to cancer patients considering entry into an early phase clinical trial.

Describe and explain complex trials information in both written and oral forms to both patients and their carers.

Describe and explain complex information to medical staff, health professionals and allied health professionals.

Negotiating the logistics of conducting a clinical trial with other departments, including across 2 research sites, under the supervision of team lead.

Give formal and informal presentation to patients, carers, health professionals and research organisations, raising awareness of clinical trials.

To communicate with other trials offices and outside organisations locally nationally and worldwide trials.

Computing skills, knowledge of MS Office application and E-mail.

Clinical Skills

1st level registered nurse or healthcare equivalent.

Health professional with experience at Band 5 in oncology and research.

Excellent knowledge of cancer terminology acquired through experience.

Adhere to Good Clinical Practice (GCP) on a day to day basis.

Adhere to research governance on a day to day basis.

Evidence of post basic education.

IV access (cannulation, PICCs, Hickman Lines and PORTS) and Venepuncture skills including ANTT.

Emergency treatment skills including treatment of anaphylaxis and other medical emergencies or willingness to gain these skills.

Use of ECG’s, B.P. machines and other equipment and to monitor patients, including invasive monitoring.

Administration of systemic anticancer treatments (completion of SACT training)

Administration of novel therapy trial drugs.

Ability to recognize potential adverse events and escalate appropriately in a timely manner. 

Screen patients to assess eligibility for study entry, ability to work on own initiative.

Able to provide expert opinion as patient advocate.

Process biological samples (PK/PD/Biomarkers etc.) as per protocol, using techniques for serum, plasma and peripheral blood lymphocyte isolation.

Prepare all samples for storage or shipping and ensure appropriate risk assessment, compliance with COSHH guidelines and safe maintenance of appropriate laboratory equipment, supplies and specimens.

Care for the acutely unwell patient, in the event of a serious adverse event requiring escalation of care to HDU/ ITU.

Assist in clinical tests where these are protocol specific.

Service Management

Co-coordinating visits for audit and monitoring of work by outside research organisations and auditors.

Knowledge of how to submit studies and amendments for required approvals in accordance with GCP, Research Governance and other regulatory requirements.

Prioritise work load when frequently interrupted.

Arrange meetings to initiate new studies.

Planning, approaching and discussions with patients/ carers.

Liaise with trial monitors from research organisations to assist with monitoring functions.

Ability to be flexible and provide cover for other team members as             required, including cross site cover at VUNHST and CVUHB.

Planning for the impact that a new clinical trial will have on various departments in VUNHST and CVUHB.

Planning the delivery and content, with Band 7 support, of educational programmes.

The ability to assess protocols for resource issues at both VUNHST and CVUHB.

Perform registration of patient to clinical trial.  Ensure accurate documentation maintained in patient records.

Liaise with research assistant and in their absence to process samples in PK/PD laboratory, using techniques for serum, plasma and peripheral blood lymphocyte isolation. 

Judgement on information giving for conflicting studies.

Help to assess feasibility of conducting complicated trials.

Effort and Environmental (physical, mental emotional and work conditions)

Use of ECG’s and other patient monitoring equipment.

Use of computers daily and for extended periods.

Administration of trial drugs.

Support for patients, carers and other team members when delivering bad news.

Quality

Advice and education given to patients and carers with respect to their disease process, management of side effects and support services available to them.

Ensure case notes are tracked on entry and leaving the unit.

Involvement in the provision of clinical advice to patients and carers.

Responsible for coordination of all clinical trial procedures of patients.

Assess patient suitability for entry into research studies.

Assess clinical care needs of patients relaying pertinent information to Consultants.

Work in close liaison with other research nurses across 2 research sites to promote team work.

Administer diaries and quality of life questionnaires to patients, provide instruction and subsequent collection.

Play 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 patients’ rights in a research setting.

·       Providing contact information to allow patients to ask questions and discuss options.

Assessing patient understanding and capability to consent.  Liaise with investigator and at all times act as patient advocate.

Supporting patients through news of their condition and treatment side-effects.

Provide first line of contact for patients and relatives with concerns or questions when at home. 

Acts as an on-going primary contact and resource throughout the duration of study intervention and follow-up. 

Provide support, information and easy contact through bleep, phone and regular communication. 

Provide referral as appropriate, liaising with primary care and other settings as required.

Co-ordination and drug administration, as appropriate, of early phase therapies including therapy not previously administered to humans.

Maximise patient safety through facilitating protocol compliance, monitoring of Adverse Events and Serious Adverse Events, timely reporting to Principal Investigator and study sponsor as appropriate.

Advice and education given to patients and carers with respect to their disease process, management of side effects and support services available to them.

Service Improvement

Adhere to Clinical Trial Unit Standard Operational Procedures (SOP) and Trust policies without supervision.

Responsible for allocated SOP update and subsequent training of staff in line with local, national and legislative changes.

Maintain and implement standard operating procedures in your specialist area.

Regularly review policy and procedures relating to the running of clinical trials.

Adhere to policy and procedures of any Local Health Board’s in South East Wales where an honorary contract may be held.

Finance and Resources

Under Team Lead supervision assess the cost implication of a study and be able to commence financial negotiations and contractual agreements with pharmaceutical companies.

Assessing the cost implications of commercial and non-commercial early phase studies under the supervision of Team Lead.

Identify with Team Lead supervision, the physical resource implications within the departments that a trial impacts upon.

Information Processing

Responsible for completion, maintenance and storage of hard copies and electronic CRF’s containing all clinical trial data in accordance with GCP legislation.

Able to receive, handle, analyse and resolve data queries promptly.

Responsibility for Research and Development

Assist team lead with initiating and coordinating a range of UK, European and World Wide early phase cancer trials for Velindre Cancer Centre, in collaboration with the relevant multi-disciplinary research teams.

Responsible for coordinating and implementing research protocols.

Assist and supervise in the preparation of submissions to appropriate committees, research and development and other bodies for approval, working in partnership with the Team Lead and trial administrator.

Promote clinical trials and create an awareness of Velindre Clinical Trials Unit and Wales Cancer Research Network amongst the NHS, and promote awareness of S E Wales early phase portfolio and activity.

Responsible for collection of complex accurate data.