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Detailed job description and main responsibilities

Clinical

• Ensure care to patients is delivered according to Trust policies and procedures and the research protocol
• Co-ordinate the care of  own case load of clinical trial / research patients in addition to oversight of junior team members caseload
• Work unsupervised in all areas related to clinical trials and research studies and supervise the work of junior team members
• Attend Multi-disciplinary Meetings, and appropriate clinics, to assess volunteers/patients for eligibility for research and recruit new patients, to act as a resource to the members of the MDT.  Communicate information regarding clinical decisions to patients, carers and the MDT as required
• Ensure that trial specific clinical investigations / procedures are undertaken as required by the research protocol in order to establish eligibility and maintain safety in the trial
• Take relevant samples as required by the study protocol such as blood samples, package and dispatch as defined. Ensure safe and appropriate storage of specimens in accordance with trial protocols and regulatory / Trust guidance
• With relevant training and assessment of competence, working within scope of professional practice, undertake clinical procedures / administer treatments associated with the research treatment regimes
• Ensure the safe administration of treatments and drugs that are given within the context of a clinical trial.
• Monitor treatment toxicity/side effects reporting to the relevant personnel, recording as required assisting in any required changes to treatment as required by the protocol
• Record and report adverse events which occur whilst patient is in the clinical trial to the relevant personnel and act as required
• Report and record serious adverse events that occur whilst the patient is being treated on a clinical trial to the trial co-coordinator/PI and relevant local personnel/regulatory authorities in a timely manner
• Maintain accurate documentation of patient’s events in nursing/medical notes. Accurately document data collected into case report forms either paper or electronically
• Provide on-going information, education and support to patients (and their significant others) regarding clinical trials and their care.  Manage difficult and or unexpected situations arising in the clinical area (i.e. bad news)
• Provide on-going follow up care whilst patient is in the clinical trial / research studies
• Refer to other specialists as required in order to provide optimal patient care
• Act as the primary point of contact for the participant
• Participate in service and policy development
• Provide support / cover for colleagues in their absence

Research

• Ensure that the delivery of studies meet the requirements with regards to the Department of Health’s Research Governance Framework for Health and Social Care and the EU Clinical Trials Directive by implementing quality systems
• Co-ordinate the delivery of a clinical trials portfolio within the relevant specialities
• Co-ordinate and lead the recruitment and retention of patients into a variety of research studies including but not restricted to clinical trials
• Participate in Good Clinical Practice training (ICH GCP) as required by the latest guidance
• Contribute to the process of gaining local regulatory committee approval
• Assist in the review of study protocols and contribute to the feasibility/study selection process, advising on safety, regulatory and logistical issue
• Work with the trials teams and investigators to develop strategies to overcome barriers to recruitment and solve other problems relating to specific studie
• Contribute to the study set up, recruitment planning and study delivery plannin
• Randomise / enrol patients into clinical trials or other research studie
• Provide on-going advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consen
• To facilitate and assist in the informed consent process ensuring that consent forms are completed accurately and filed as required and participants are fully aware of the nature of the stud
• Following appropriate training and competence assessment obtain written informed consent from participants for allocated research studies in accordance with study protocol and Trust guidanc
• Ensure clear, concise and accurate records are kept for research projects in accordance with all regulatory requirements including the data protection act
• Ensure that all ICH GCP required documentation is kept in a clearly traceable system and is stored in an appropriate manner for the appropriate length of tim
• Where required, data is transcribed accurately into the Trial Master File and maintain in accordance with ICH GC
• Plan, prepare and participate in monitoring and audit visits. Respond to data queries generated by the study co-ordinating team within a timely manner. Liaises with trial personnel outside of the hospital as necessar
• Assess and evaluate the progress of on-going trials for which the post holder has responsibility
• Maintain accurate records of study recruitment as per local procedure and status of studies providing regular updates. This will involve ensuring that EDGE (local patient management system) is updated with key trial data and feeding back through the local  portfolio team meeting
• Utilise and ensure others utilise information and IT systems to secure accurate and timely patient, workforce and resource dat
• Escalate on-going study performance issues to the Senior Research Sister/Charge Nurse in a timely manne
• Safeguard the integrity of the study by ensuring compliance with ICH GCP guideline
• Co-operate with external and internal audit, data monitoring and quality assurance by working with RD&I, Sponsors , study monitors and external bodie
• Assist in study close down procedures.

Management

• Manage a designated number of studie
• Recognise and report / manage any complaints from patients/ carers
• Take responsibility for the supervision of junior research nurses and act as a resource to ensure they optimise their clinical research skills and potential.
• Assist in the education and support of other health care professionals to enable them to care for patients participating in clinical trials or other research studies
• Respond to change in line with the needs of the service
• Use judgement in relation to competing demands for staff and resources
• Assist in the effective recruitment and selection of staff in line with the Trust’s recruitment and Selection process as require
• Assist in the Trust performance review process for junior research nurses and other appropriately allocated staff within the team
• Ensure performance issues within the team are dealt with in an appropriate and timely manner by escalating issues to the responsible Senior Research Nurse 

Personal education and development

• Keep updated with Departmental, Trust, NHS and relevant statutory developments for the management of clinical research
• Maintain an up to date knowledge of research related articles particularly related to clinical trials and research studies
• Be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with NMC requirements
• Maintain links with other research nurses and multidisciplinary teams across the Trust and network to share knowledge and to provide mutual support
• Attend local Trust and national meetings in relation to research trials as appropriate and agreed with line manage

Other:

• To work within the NMC Code of Conduct and within individual scope of professional conduct
• Undertake all Trust mandatory training as per Trust procedures and policies
• To maintain patient confidentiality at all times.

For full job description please see attached in supporting information