Research And Development Commercial Research Coordinator

Research and Development Commercial Research Coordinator The closing date is 16 December An exciting opportunity has arisen for a highly motivated individual to join our R&D Governance team supporting cutting edge research - research that builds on scientific discoveries, turning them into new ways to detect, diagnose, treat and ultimately prevent disease. The Trust's R&D Department is responsible for the governance of all research studies taking place at Cambridge University Hospitals. You will be part of the Research Governance team supporting the set up of commercial research and facilitating their approval. Ideally you will be of Graduate calibre and have recent experience of working within a clinical research environment on commercial trials. Detailed knowledge and understanding of research governance including ethical issues, the regulatory framework and costing and contracting for research is desirable. You should also have excellent communication skills in order to assist and guide researchers at all levels. In addition you will need to be organised, proactive, methodical and able to work autonomously and with a high level of initiative. Main duties of the job Be part of the R&D Governance team to support the set-up of commercial studies. Manage the EoI, Feasibility and site selection aspects of trial set up for commercial research, including highlighting opportunities to potential Principal Investigators for involvement in new commercial trials, working with PIs to submit expressions of interest / feasibility questionnaires, track and record EoI / feasibility responses. Liaise with teams / Sponsors / CROs on site selection agreements, negotiating key milestones for the Trust, managing and attending SSVs ensuring all necessary staff / departments are aware of the requirements and timelines for studies the Trust is selected to take part in and can confirm their capacity in advance of set up. Work with support departments to put in place an efficient system to obtain authorisations for commercial studies and track to time and target. Maintain close communication with support department leads for updates, reporting back to R&D governance / study teams on any changes that could affect study approvals. Quality check and assist in completion of support department application forms for accuracy, ensuring submission to committee meeting deadlines. Review study budgets and contracts in line with national and Trust KPIs for confirmation of capacity and capability to take part in the trial. Management of commercial study finances, recording on relevant systems for Trust invoicing. About us Our Trust Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population. CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background. Benefits to you At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff. On CUH campus, hot food is available 24 / 7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH. CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times. Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered. We welcome applications from the Armed Forces. Qualifications GCP training Post graduate research qualification Experience Experience of working in a research environment on commercial trials (NHS, University or industry) Experience in research governance setting up clinical trials and negotiating research contracts Experience working in research finance Experience in data coordination, working with research databases Experience of working within a clinical research setting Experience costing commercial trials Knowledge Demonstrable understanding of research governance and the processes for setting up commercial research in the UK Knowledge and understanding of funding and costing of commercial research and NCVR Knowledge of the regulatory framework for research including the UK Research Governance Policy Framework for Health and Social Care Research Knowledge and understanding of agreements used in commercial research Knowledge of commercial organisations and external agencies within clinical research Knowledge of research databases used to record and analyse data Understanding of the ethical issues in clinical research Knowledge of the MHRA regulations for medicine and device trials Skills Demonstratable communication, organisational and planning skills Excellent interpersonal skills including the ability to build working relationships with department colleagues, Trust staff at all levels and external organisations such as commercial sponsors in industry, CROs, Universities and other NHS Trusts Excellent IT skills including the recording of data within electronic databases Ability to work under pressure balancing conflicting workloads Ability to work independently with initiative and maintain confidentiality Be proactive and work methodically Ability to negotiate, acting in a tactful and confident manner to achieve the desired results Ability to make well reasoned decisions using sound judgement in a complex setting Ability to use databases to record data Additional Requirements The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent. Keep up to date with changes in local and national guidelines / legislative requirements. Disclosure and Barring Service Check. This post is subject to the Rehabilitation of Offenders Act (Exceptions Order). It will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. #J-18808-Ljbffr