Job overview The Liver clinical trials team at Kingu2019s College Hospital are inviting applications for a clinical trials coordinator to work alongside the clinical trials team on an exciting portfolio of commercially funded and investigator led studies in liver diseases. The successful applicant will be an enthusiastic and motivated individual who will be responsible for assisting the liver research team with facilitation, set up and ongoing administrative oversight of portfolio adopted and commercial studies. This is a senior role and the post-holder will be required to manage a team of administrators and data managers who perform a variety of administrative tasks.u00a0 Previous experience working within the area of clinical trials is essential; and the successful applicant will be expected to have thorough knowledge of the research governance process; along with the structure of research within the UK and guidelines relating to Good Clinical Practice. u00a0Experience of working with commercial sponsors would be desirable but applicants with other experience that may be applied to this setting would be considered. Administration skills, IT skills, prioritisation and organisational skills along with excellent communication are essential for this role. You must also demonstrate the ability to manage your own work load effectively in a busy environment. Informal visits are encouraged. Please contact Andrew Ayersu00a0 andrew.ayersnhs.net or phone 02032997615 to arrange. Main duties of the job Coordinate all aspects of the set up and day to day conduct of clinical trials/studies from set-up to close down in accordance with ICH GCP, NHS Research Governance and, for Clinical Trials of Investigational Medicinal Products (CTIMPs), the EU Directive on clinical trials. Develop and/or review other essential clinical research documents including patient information sheets/letters, informed consent forms as well as regulatory paperwork ensuring compliance with relevant Liver Research SOPs, legislative requirements and GCP guidelines. Prepare, submit and manage amendments to essential clinical research documentation. Coordinating Site Initiation Visits and taking action on pre SIV activities Oversee Invoicing for Clinical Trial activity Assist with costing studies both at NCVR level and locally Develop and maintain systems for tracking trial conduct, recruitment and data capture. Collect and report safety information according to Kingu2019s CRF established procedures. See attached Working for our organisation Kingu2019s College Hospital NHS Foundation Trust is one of the UKu2019s largest and busiest teaching Trusts with a turnover of cu00a31 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders inu00a0 Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do.u00a0 The Liver Research team at the Institute of Liver Studies in Kings College Hospital has an extensive portfolio covering a range of studies from observational cohort studies to interventional (phase 1-3) trials for various liver diseases; and has developed a reputation Internationally for excellence in research delivery.u00a0 Detailed job description and main responsibilities Administrative u2022 Provide oversight and supervision to junior members of the administrative team, ensuring high quality of service provision. u2022 Ensure that clinical data management systems for research are in line with data requirements to meet the principles of Good Clinical Practice (GCP) for research, in providing public assurance that clinical trial data are credible, by supporting study set up, progress and close down process. u2022 Ensure that robust data is entered into relevant database systems. u2022 Drive the improvement in data quality and escalate any areas of non-compliance where appropriate. Perform data cleansing tasks as required to ensure accuracy of data and maintain data integrity. u2022 The role includes providing expert advice to investigators, to ensure that all regulatory requirements are met, advising on new systems being introduced by the Health Research Authority and that all the necessary negotiations with service leads and other stakeholders are concluded satisfactorily. u2022 Provide reports and metrics to inform the feasibility assessment process u2022 Actively participate in the planning, and conduct of monitoring programmes, audit and activities (both external and internal) to ensure that research activities are carried out within the GCP Framework u2022 Contribute to the development of research policy and work processes. u2022 Maintain a database of staff involved in Liver research and coordinate re-training of staff who require it u2022 Process amendments and disseminate information to relevant departments u2022 Coordinate staff training for study amendments and ensure the process is documented as per regulatory requirements Research Facilitation u2022 Lead the preparation of feasibility assessments undertaken by the study team and R&I lead, to ensure that there is organisational capacity to undertake the research and deliver to time and target. u2022 Responsible for communicating with KHP CTO, KCH (and/or other affiliated Trusts) and KCH clinical service leads to ensure that there is sufficient capacity and resource to carry out new research projects. u2022 Advise research teams on the timelines and process which will be undertaken by the CTO and/or R&I office before research can begin at KCH. u2022 Undertake assessments of new projects in a timely and accurate manner, maintaining records of progress and communicating outcomes to the research teams and stakeholders. u2022 Communicate with external stakeholders, primarily commercial sponsors and their delegated CROs to ensure all KHP projects are delivered as per contractual obligations. u2022 To facilitate increased clinical research activity within KCH and ensure that it complies with the necessary governance and regulatory frameworks for research. Finance u2022 Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract. u2022 Collect and provide information to allow for invoices to be raised for payments where appropriate. u2022 Assist in obtaining costings for grants and other awards liaising with the necessary personnel in R&I finance and R&I costings; ensuring that all processes align with trust policies and funding body requirements. Person specification Qualifications Essential criteria Relevant degree or professional qualification or equivalent experience Significant postgraduate training (Diploma) or equivalent experience to masters level Desirable criteria Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields Experience Essential criteria Significant experience in a research administration/management role in either NHS, academic or corporate environment with demonstrable achievement Knowledge and experience of working with research systems in healthcare. Thorough working knowledge of research processes and governance Excellent IT skills including database usage (i.e. data entry and reporting) Desirable criteria Experience in the conduct/delivery of research Audit and monitoring experience Decision Making, Planning and Problem Solving Essential criteria Ability to analyse and interpret research project information and ability to make judgements regarding a range of highly complex research management issues Ability to make informed decisions and to provide advice and guidance to staff of wide ranging experience and knowledge Excellent analytical approach to problem solving and careful attention to detail Communication and Networking Essential criteria Work closely with clinical, academic and other staff at all levels and across the partner organisations and to develop effective working relationships Excellent oral and written communication skills to communicate effectively with researchers, consultants and staff from different disciplines and administrators at all levels Ability to communicate complex regulatory and other technical information in an easily understood manner Employer certification / accreditation badges Applicant requirements The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.