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Detailed job description and main responsibilities

Responsible to the Head of Research and  Research Operations Manager

KEY TASKS & RESPONSIBILITIES:

 CLINICAL RESPONSIBILITIES

• Work autonomously and assist in the management of a caseload of clinical trial patients whilst working as part of a multi-disciplinary team.  Maintain effective communication with patients, carers and professionals to ensure high quality service delivery
• Identify suitable patients for entry into clinical trials by attending clinics (screening notes) and relevant Multi-disciplinary Team meetings
• Maintain accurate documentation of patient events in maternity/medical notes
• Ensure patients are fully informed prior to entry into clinical trial programmes
• Demonstrate a comprehensive understanding of treatment options, treatment side effects and disease processes to support patients in making an informed treatment choice
• Provide ongoing information, education and support to patients (and their significant others), all levels of maternity staff regarding clinical trials and specific trial treatments
• Take and assist in consenting patients, randomise patients to treatment arms
• Ensure that trial specific investigations are undertaken as required by the trial protocol and obtain results in order to establish eligibility and safety to enter the trial
• Ensure the safe administration of treatments and drugs that are given within the context of a clinical trial.  
• Monitor treatment toxicity/side effects and initiate changes to treatment or treatment cessation as required by trial protocols
• Report and record adverse events which occur whilst patients are under trial therapy to the trial co-ordinator/Principal Investigator and relevant local and regulatory authorities
• Provide continuity of care to patients and their carers throughout the trial programme.   Provide specific advice and psychological support as appropriate.  Refer to other specialists as required to ensure optimum patient care.
• Act as a primary contact point for the trial participant
• Maintain accurate patient trial documentation, complete Case Report Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients’ medical notes. Ensure that the EDGE integrated Research database is kept up to date with all trial related activity.
• Perform phlebotomy, blood and urine spinning as required by trial protocols, ensure the safe handling, storage and transportation of samples

RESEARCH

• Work collaboratively with the KSS-CRN, the Lead Research Nurse, the Research and Development Department, the existing clinical trials team, multi-disciplinary teams and Allied Health Professionals to assist in maintaining and developing a clinical trials service at Frimley Health NHS Foundation Trust.
• Implement and adhere to the principles of the International Conference of Harmonisation and Good Clinical Practice (ICH GCP), research governance standards and UK Clinical Trial Regulations where appropriate.
• Support the identification of suitable new UKCRN trials for the Frimley Health R&D portfolio
• Support the set up and management of a UKCRN portfolio of trials
• Identify and screen for potential research participants.
• Act as a Principal Investigator for non-clinical trials of an investigational medicinal product (Non-CTIMP) study.
• Identify strategies for the recruitment of patients into trials, ascertain barriers to recruitment and implement action as required 
• Facilitate the informed consent process by ensuring the following:

1. The patient (and significant others) fully understands the nature of the clinical trial
2. The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice
3. The patient is aware of any extra procedures required by the trial
4. The consent form is completed accurately and filed as required

• Provide support to UKCRN hosted clinical trials in the absence of colleagues across specialties
• Ensure that data is accurately collected and appropriately stored into databases.  Forward to trial co-ordinating centres in a timely manner as necessary
• Undertake audit, as required by the R&D department at the FHFT Hospital sites.
• Assist Clinical Research Associates monitoring allocated studies with data verification and queries.
• Ensure that follow up visits for research participants are conducted according to study protocol.
• Act as a role model for excellence in the research process

MANAGEMENT

• To act as clinical supervisor to junior research staff within the department and act as a role model for excellence in clinical research.
• Be responsible for the line management of junior members of the research team.  Oversee the induction, orientation and training of new clinical trial staff to the team.
• Promote and support the continued development of the clinical trials service at Frimley Health NHS Foundation Trust
• Support the development, continued growth and maintenance of the nursing research service and assist in the review and audit annually
• To report to the clinical governance team any adverse incident/near misses in relation to that activity.
• Liaise with members of the multi-disciplinary team i.e. Pharmacists, Radiologists, Pathologists to ensure safe and smooth running of trials
• To troubleshoot and identify problems to ensure smooth running of the research projects.
• Support the co-ordination, preparation and submission of research to the relevant NHS REC and HRA for approval. Manage amendments to allocated trials by preparing and providing relevant documentation for local R&D submission.
• Ensure that all research governance approvals (both locally and externally) are in place prior to commencing the trial
• Contribute to the development of clinical and research policies, procedures and Trust standard operating procedures (SOPs)
• Input and maintain data recorded on the EDGE project management system used at the Trust 
• Ensure that clinical trial recruitment records are accurately maintained
• Ensure that clinical trials are effectively archived as required
• Manage and prioritise time effectively
• Be aware of the Trust’s complaints procedure and role of PALS (Patient Advice and Liaison Service).  Prepare accurate statements in response to incidents and complaints
• Undertake regular individual performance review in conjunction with the Lead Research Nurse. Agree personal professional development plans in line with service objectives, Network and Department of Health initiatives
• Assist in the preparation of budgets for clinical trials
• Attend relevant specialist nurse forums at Trust level as required
• Be prepared to travel off-site as necessary, to attend meetings, clinics

EDUCATION AND DEVELOPMENT

• Act as a resource for colleagues and patients in relation to clinical trials.  Ensure all relevant health care professionals are educated and supported as required enabling them to care for clinical trial patients
• Represent Frimley Health NHS Foundation Trust as an expert research nurse in external events such as national and international conferences, committees etc.
• Participate in the identification of training and education needs of Trust staff and support the planning, organisation and presentation of educational programmes relating to research
• Attend trial investigator/research nurse meetings and conferences when required
• Maintain links with other clinical trial nurses and clinical nurse specialists across the network to share knowledge and to provide mutual support
• Maintain awareness of current advances in relevant treatments, research and nursing practice and use this knowledge to maintain high standards of care for patients
• Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications
• Attend relevant MDTs, working groups and business meetings to disseminate information about performance and to speak about potential new clinical trials and service development as required
• Assist in the development of Patient Information and information to General Practitioners for patients participating in clinical trials
• Continually update and maintain own professional development in research through attendance at local and national training programmes and other relevant education and training programmes
• Disseminate findings from own professional development using written reports, presentations and the implementation of educational initiatives
• Maintain an up-to-date knowledge of research related articles particularly those related to clinical trials and contribute to the service’s database

PROFESSIONAL

• Registered nurses to Work within the NMC Scope of Professional Practice and Code of Conduct
• Attend mandatory lectures and training as set out in the Trust guidelines
• Act in accordance with local policies and procedures laid down by Frimley Health NHS Foundation Trust
• Be aware of the Trust’s complaints procedure and role of the PALS Team