Clinical Trial Co-ordinator

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Our client are a cutting-edge, digital health organisation focused on diabetes. They have developed a digital product and application which allows patients to manage their condition through personalised risk prediction, provision of advice selected tailored to the individual and also the ability for remote monitoring by the GP.They continue to conduct trials to establish real world evidence of efficacy and health economic benefits of their products and so are looking to hire a Clinical Trials Co-ordinator.This is an exciting time to join the company as they expand their partnerships with leading pharmaceutical partners globally, the NHS in the UK and embark upon a period of rapid growth.Job Purpose:The clinical trials co-ordinator will have the leading role in planning, coordinating and executing clinical trial projects for all aspects of the business.As the designated clinical trials co-ordinator communication and presentation skills are important, together with the ability to organise and motivate.Previous experience in the management and co-ordination of clinical trials is essential together with the appropriate academic and/or vocational qualifications working in the field of diabetes management and treatment.ResponsibilitiesProvide clinical advice and guidance to the and clinical test design team to ensure compliance with applicable regulations;Responsible for helping set-up successive and future rounds of clinical trials;Assist with compiling and submitting grant applications;Review and advise on the clinical content within the mobile app platform;Write and maintain clinical evaluation reports to meet the requirements of the EU Medical Device Regulation;Manage post-market surveillance/post market clinical follow-up activities if applicableDesign, develop, and execute protocols for clinical trials in line with regulations and standards.Establish and maintain procedures to ensure adherence to trial protocols and administrative requirements.Creation and maintenance of all trial files, including the trial master file, and oversight of site files;=Write clinical trial notifications and investigational device exemptions for submission to regulatory bodies where applicableManage the overall efficient day-to-day management of the trials. This may include third party clinical trial organisations etc.Management of the trial budget(s) and maintenance of the accountsWrite study documents, reports, and summaries of adverse eventsSubmit reportable adverse events from clinical trials to applicable external bodies within legislated timelines along with internal stakeholdersDevelop and implement enrolment strategies and monitoringMonitor and track progress and obstacles during clinical trial, responding to day-to-day problemsWork with external institutions and clinical staff where necessaryAnalyse data based on trial results, interpreting research information, and creating detailed documentation using to inform clinical proceduresPrepare manuals and present conclusions at conferences and seminars where applicableAssist with budget preparation;Act as the point of contact for all external and internal agenciesLiaison with the Trials Steering Committee and Data Monitoring and Ethics Committee as necessaryAssurance that personal and confidential information is restricted to those entitled to knowUndertake any other reasonable duties as requested by the line manager;Education/Qualifications/ExperienceIdeally degree educated or equivalent practical work experienceIdeally a trained diabetes nurse with clinical background To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales