JOB PURPOSE The post-holder is responsible for supporting and administering all clinical research within Research and Innovation at Leeds Teaching Hospitals NHS Trust under the guidance of the Senior Research Nurse/Midwife/researcher. The post-holder must ensure that all trial protocols are adhered to in line with ICH-GCP practice. The post-holder will act as Assistant to the Senior Research Nurse/Midwife/researcher and will liaise with all internal and external parties involved in the setting up, maintenance and closure of research studies. The post-holder will assist with administrative aspects of clinical research/trials management including costings. The post holder may be expected to interact with patients and their families in relation to the requirements of the research study and be able to work without supervision in some areas. A key component of the post is to carry out the informed consent process with patients as appropriate and following specific training, and administer the necessary paperwork and maintaining a clear audit trail. You will have responsibility for logging of all patients into the EDGE research database and departmental clinical trials database ensuring information is accurate and up-to-date. Your role may also include some clinical skills such as taking clinical observations, venepuncture, taking electrocardiography (ECG) tracings and processing clinical samples. JOB DIMENSIONS The post holder will be working within a busy Clinical research department with a large portfolio of studies covering a range of conditions. Studies include those funded by the NIHR, commercial trails, academic studies and early phase (experimental) therapies. Clinical trials support is provided to the research team and the numbers of patients in trials can range from 1 to 50+. The post holder is expected to meet all reporting procedure timescales and international, national and local standards for clinical trial governance. The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED Qualifications Literate and numerate Good standard of education to a minimum of NVQ level 3 or equivalent Experience Previous administrative experience Clinical trials experience Experience working in the NHS having contact with patients in either a clinical or research setting Informed consent experience (desirable) Training Willing to undergo training as required Good Clinical Practice (GCP) training Specialist Knowledge Insight into role and responsibilities of post Knowledge of research methodologies Understanding of the NHS Disposition/Attitude Able to work as part of a multidisciplinary team Committed to working with people Good communicator Able to work on own using own initiative Practical Skills Good interpersonal skills Excellent IT skills Effectively communicate with multidisciplinary team members Ability to pay attention to detail Time management skills Previous clinical skills training e.g. taking clinical observations, venepuncture or taking ECGs (desirable but not essential) LEEDS WAY VALUES Our values are part of what make us different from other trusts, so we see this as a strength, as well as a responsibility. They have been developed by our staff and set out what they see as important to how we work. Our five values are: Patient-centred Collaborative Fair Accountable Empowered All our actions and endeavours will be guided and evaluated through these values Additionally the following are core values which relate specifically to this post: Commitment to supporting patients and their carers through the complexities and ethical dilemmas of decision making with regard to participation in a research project Commitment to meticulous and consistent attention to quality and detail Commitment to working in a multi-disciplinary team Commitment to own development and the development of junior staff Commitment to maintain high standards of care in accordance with Leeds Teaching Hospitals NHS Trust (LTHT) guidelines and policies. Commitment to the development of nursing within the clinical setting. Commitment to lifelong learning, to maintain personal development within the role. The post requires an organised approach to working, a willingness to learn, dedication and attention to detail. An honest and open approach in all working relationships is required WEST YORKSHIRE ASSOCIATION OF ACUTE TRUSTS (WYAAT) Leeds Teaching Hospitals NHS Trust is part of the West Yorkshire Association of Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across West Yorkshire and Harrogate working together to provide the best possible care for our patients. By bringing together the wide range of skills and expertise across West Yorkshire and Harrogate we are working differently, innovating and driving forward change to deliver the highest quality care. By working for Leeds Teaching Hospitals NHS Trust this is your opportunity to be a part of that change. WYAAT is the acute sector arm of the West Yorkshire and Harrogate Health and Care Partnership, one of the largest integrated care systems in the country. The Partnerships ambition is for everyone to have the best possible health and wellbeing, and the work of WYAAT, and each individual trust, supports that ambition CORE BEHAVIOURS AND SKILLS Motivated Professional attitude and behaviour Able to adapt to service led changes Flexible approach to working practices and duties Able to work on own or as part of a team Attention to detail Time management skills Able to use own initiative Excellent IT skills Good written and oral communication skills with the ability to communicate with staff at all levels Reliable, trustworthy and honest approach to work and colleagues Fair approach when dealing with colleagues and team CORE KNOWLEDGE AND UNDERSTANDING The post holder will have an understanding of the principals of clinical research and be expected to develop a working knowledge of clinical research. The post holder will have the ability to comply with ICH GCP guidelines for clinical research as well as the LTH Trust guidelines and policies. The post holder will be familiar with the process of clinical trials and be willing to undergo further training as required to gain the knowledge shortly after entering the post.