Clinical Trials Coordinator | Cambridge University Hospitals NHS Foundation Trust
Be an integral part of the clinical trials team in Paediatric Neurology. Ensuring all trials are opened to a robust time frame, enabling novel treatments/ investigations to be available to patients.
This is a crucial role in ensuring trails involving children and young people treated within Paediatric Neurology at Cambridge University Hospitals NHS Foundation Trust (CUH) are properly conducted according to Good Clinical Practice (GCP), Research Governance Framework and are compliant with the EU / UK directive for clinical trials.The Paediatric Neurology team is part of Women’s and Children’s Services at CUH, currently running a number of national and international clinical trials and serves the population of the East of England.The team are looking to support access to research and trials and this role is crucial to that.
The post is part of a small team responsible for new and existing clinical trials and clinical research projects within the Paediatric Neurology portfolio, including Clinical Trials of Investigational Medicinal Products.
To facilitate and co-ordinate the set-up and conduct of clinical trials and/or clinical studies working closely with Principal Investigators and their teams, research nurses and trials assistants.
Ensuring that all data is collected following the appropriate protocols.
To work in compliance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the NHS Research Governance Framework for Health & Social Care and, in the case of a CTIMP, in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004.
The Clinical Trials Coordinator is responsible alongside PIs for implementation of GCP, undertaking and supporting ethical committee applications for local approval, R&D submissions and Serious Adverse Events (SAE) reporting.
This post is also responsible for document control and dissemination, including keeping appropriate records; protocol review as part of studies and the development and maintenance of all trial site files relating to studies. In the event of a statutory GCP inspection, the Clinical Trials Coordinator would assume responsibility for preparation of all documentation and arrangements for the inspection in support of the relevant Principal Investigators (PIs)
The Trials Coordinator will work closely with the Paediatric Neurology Research Lead, PIs, Research Nurses and Trials Assistants to support staff working on research and trials.
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke’s Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 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.
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 19th September 2024.
Interviews are due to be held on the 4th October 2024.
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 café, 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.
This advert closes on Thursday 19 Sep 2024