Job summaryA new opportunity has arisen for a Clinical Trial Co-ordinator at the Heart and Lung Research Institute Clinical Research Facility (HLRI CRF) The HLRI CRF is a joint project between the University of Cambridge (University) and Royal Papworth Hospital (RPH) to create a world-leading research environment delivering high impact research, directly impacting on global cardiovascular and respiratory health. It Is a state-of-the-art facility for delivery of clinical trials.The main aim of the post-holder is to assist with setting up clinical trials, arranging study visits, maintaining up to date files of all essential documents, including Trial Site Files and assisting with regulatory approvals. They will support senior research colleagues to ensure that specified milestones are achieved on time and demonstrate that high quality data is being collected and that the trial is being conducted according to the ethically approved protocol and ICH-GCP standards. They will also coordinate data collection and data entry and responding to everyday queries from research nursing team and study participants including coordination and managing assessments and follow up episodes specified by the protocol.We offer a friendly working environment and are interested in your career development with a range of training opportunities available to help you fulfil your potential.You will be based at the new Heart Lung Research Institute (HLRI) and Royal Papworth Hospital on the Cambridge Biomedical Campus.Main duties of the jobAs a key member of the Research Team, you will be supporting the work at the Heart and Lung Research Institute Clinical Research Facility.*Liaise with key colleagues in RPH and sponsors to ensure appropriate set-up and conduct of clinical trials or research projects.*To arrange monitoring visits, maintaining up to date files of all essential documents, including Trial Site Files and assisting with regulatory approvals.*Liaise on a regular basis with relevant RPH colleagues, visitors, patients and external organizations, e.g trial sponsors and stakeholders.*Assist with the maintenance of standard operating procedures and quality management systems.*To support the work at the HLRI CRF team to ensure the delivery of a comprehensive, high-quality service within the CRF in accordance with Trust Policies, R&D SOPs, Good Clinical Practice (GCP) and all other regulatory requirements.*To contribute to the implementation, monitoring, improving and management of the CRF's Operations, policies and SOP and support its alignment with the R&D and RPH research standards.The successful applicant will be part of the Clinical Research Facility (CRF) team undertaking trials within the Royal Papworth Hospital NHS Foundation Trust. They will liaise closely with CRF team members, clinical trial delivery teams, R&D team and study sponsor representatives. They will be expected to operate with minimum supervision in organising and planning their own work activities.About usRoyal Papworth Hospital NHS Foundation Trust is the UK's leading heart and lung hospital, delivering care to more than 50,000 patients a year in its new state-of-the-art hospital in Cambridge. We perform the most heart and/or lung transplants in the UK and carried out the UK's first successful heart transplant in 1979. It also offers emergency heart attack treatment, sleep centre care and is one of just five centres nationally for those in severe respiratory failure.Based on the Cambridge Biomedical Campus the largest centre of medical research and health science in Europe the Trust is at the heart of treatments of the future. Royal Papworth became the first hospital trust in the country to be rated outstanding in all five areas assessed by the Care Quality Commission - a rating it still holds today. The Trust holds its values of compassion, excellence & collaboration at its core, and all colleagues joining the team are expected to uphold these in their day-to-day roles & interactions. Royal Papworth is proud of its diverse workforce and encourages people to embrace their individuality.The Trust values difference and welcomes all applications irrespective of age, disability, gender reassignment, marriage and civil partnership, pregnancy & maternity, race, religion & belief, sex and sexual orientation. Providing they meet the minimum post criteria, applicants with disabilities will be offered an interview.For a street view tour: https://royalpapworth.nhs.uk/virtual-tourJob descriptionJob responsibilitiesOn this page you will find a Role Profile which provides information about the hospital and full details about the role. We recommend that you review this and refer to it as you complete your application. Please include how you will meet the Trust Values Compassion, Excellence and Collaboration. If you would like more information about the role or working at Royal Papworth Hospital, please get in touch with the contact for this role.Person SpecificationQualificationsEssentialScience graduate or equivalent level of Knowledge and experienceDesirableRecent ICH GCP TrainingExperienceEssentialExperience of working in a clinical research environment within NHS,University or pharmaceutical industryExperience of working with multi-disciplinary teams.Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stageUse of databases to record dataPresent data in clear and simple formatUse of Microsoft Office to an advanced levelCompetence in using the Internet and E-mailExcellent communication skills both written and verbal.Understand importance of accurate data collection and recording for clinical use.Proficient in the use of Microsoft Office programmes.Excellent administrative skills including organising and planningExcellent attention to detailAbility to work under pressure, prioritise and seek input where necessary.Ability to work independently with initiative and motivate self and othersHelpful, outgoing team workerPositive attitude to change.The ability to make changes to own practice and offer suggestions for improving services across the department.Able to support senior colleagues with implementation of Standard Operating Procedures in own area of practice.Maintains the quality in own work and encourages others to do the same.Ability to maintain confidentialityDesirablePrevious direct clinical trial coordination and/or administration experienceKnowledge and understanding of ICH Good Clinical Practice.Clinical trials terminology and essential documentationAn understanding of the clinical research approval process in the NHSExperience with site file maintenance and assisting with external on-site monitoring visitsSupporting with the set-up of clinical trials.Experience within feasibility process.Clinical skills -- ECG, venepuncture, spirometry.Basic laboratory skills e.g. use of centrifuge, pipetting, aliquoting.Experienced in use of databases/database applications.Confident in handling large sets of data.Additional CriteriaEssentialPlease provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, CollaborationWillingness to undertake relevant training required for role e.g. competency training, Research Skills training, Consent training etc.Flexible approach to working hours and practices.Supportive of equality and values diversity.DesirableDemonstrable commitment to working as part of a team to achieve shared goals.Disclosure and Barring Service CheckThis post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such 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.Employer detailsEmployer nameRoyal Papworth Hospital NHS Foundation TrustAddressHeart and Lung Research InstitutePapworth RoadCambridge Bio Medical CampusCambridgeCB2 0AYEmployer's websitehttps://royalpapworth.nhs.uk/working-here (Opens in a new tab)