Generic Research Nurse / Clinical Trials Practitioner

Job description MAIN DUTIES & RESPONSIBILITIES CLINICAL To work collaboratively with the research team to manage a caseload of research studies, maintaining effective communication with patients, carers and healthcare professionals to ensure high quality service delivery. To ensure that research study specific investigations are undertaken as required by the trial protocol in order to establish eligibility and safety to enter the trial. To act as a resource and support to patients and carers, explaining practical aspects of research studies and working with clinical teams to map patient pathways as required. To arrange collection of samples required as part of the research study and ensure safe and appropriate storage of specimens in conjunction with local support services staff. To maintain accurate, contemporaneous patient records and ensure all relevant information is documented in the patients healthcare records and uploaded to EVOLVE. To be responsible for accurate and timely completion of case report forms (CRFs). To monitor participants for toxicity/side effects and inform the PI or other Drs on the delegation log to ensure that changes to treatment are effected as required by the research study protocol. Report and record all serious (SAE)and adverse events (AE), within the required time period, that occur whilst the patient is in the study to the Principal Investigator, research study personnel as required and through the Trust reporting system. MANAGEMENT AND ADMINISTRATION To ensure that research study recruitment records are accurately maintained and data contemporaneously recorded in healthcare records and on the case report form (CRF). To maintain study site files and documentation. To liaise with Trust support services as required by the research protocol e.g. radiology, laboratory or pharmacy to ensure safe and smooth running of the study. To access appropriate computer systems in order to retrieve relevant information. To ensure that research studies are effectively archived as required in compliance with GCP principles and trust policies. To provide information as required for the raising of invoices related to research studies. To provide support for research colleagues and attend meetings relevant to the post. EDUCATION AND TRAINING To act as a resource for colleagues in relation to research studies. To assist in the education of all relevant health care professionals to enable them to care for research study patients in the trial. To keep all appropriate staff informed of the progress of research studies. To keep up-to-date on research related topics in general and as appropriate to caseload and interest. RESEARCH AND AUDIT To contribute to the management of the local portfolio of research studies and assist in the identification of research studies for introduction to research teams. To maintain and expand understanding of research governance and the implication to research. To identify patients eligible to enter research studies, assisting with registering and randomising patients into Clinical Trials as required and completing pre-study tests where necessary. To facilitate the informed consent process ensuring the following is accounted for: The patient (and significant others if appropriate) fully understand the nature of the research study. 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. If the protocol allows, it may be necessary for the post holder to gain written informed consent from participants for observational studies. The consent form is copied to the correct people and filed as per the protocol. Distribute questionnaires according to the protocol To be responsible for the forwarding of research study data in a timely manner including screening of potential patients for Clinical Trials and a preliminary evaluation of eligibility. To assist the clinical service and wider research team with the production of a research participant recruitment and retention strategy for each assigned research study. To accurately record data on trial pro-forma, co-ordinate monitoring visits from sponsoring companies and respond promptly to data queries. PROFESSIONAL RESPONSIBILITIES Work within the NMC Code of Conduct or within the scope of practice and the standards of proficiency as applicable Be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with re-validation requirements. Conduct the research in accordance with the relevant guidelines including GCP, and UK policy framework for health and social care research in order to protect the research participants and the quality of each study. To safeguard interest of patients by liaison with relevant trial personnel and ensure compliance with research guidelines. To observe the confidentiality of participant information at all times, in accordance with the Data Protection Act 2018.