Research Nurse - Diabetes
Our client is a fast growing digital health company established to help people with diabetes live better with their condition through the use of a mobile app, they provide clinical guidance and personalized risk scores based on the User's clinical history and management of the condition. It also allows registered GPs to monitor their patients remotely via a web-based dashboard.
The Research Nurse will have the leading role in planning, coordinating and executing clinical trial projects for all aspects of the business.
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.
Key Role Responsibilities
- Assist with compiling and submitting grant applications;
- Review and advise on the clinical content within the platform;
- Liaison with users of the app to understand clinical needs and queries
- The Research Nurse will provide clinical advice and guidance to the and clinical test design team to ensure compliance with applicable regulations;
- Responsible for setting-up clinical research projects including applying for funding via SBRI, Innovate UK and other bodies;
- Write and maintain clinical evaluation reports to meet the requirements of the EU Medical Device Regulation (ideally);
- Assist with budget preparation;
- Management of the trial budget(s) and maintenance of the accounts;
- Design, develop, and execute protocols for clinical trials in line with regulations and standards. Ensure these are clearly understood and followed by all partners and team members;
- Creation and maintenance of all trial files, including the trial master file, and oversight of site files;
- Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee as necessary;
- Assurance that personal and confidential information is restricted to those entitled to know;
- Write study documents, reports, and summaries of adverse events;
- Establish and maintain procedures to ensure adherence to trial protocols and administrative requirements. Ensure these are clearly understood and followed by all partners and team members;
- Submit reportable adverse events from clinical trials to applicable external bodies within legislated timelines;
- The Research Nurse will manage the overall efficient day-to-day management of the trials through third party clinical trial organisations;
- Develop and implement enrolment strategies and monitoring;
- Working with primary care sites to ensure uptake where CCG pilots and trials have been agreed;
- Assist with training and on-boarding of patients into trials - therefore travel to practices within CCG pilots will be required to enable set-up and monitor the progress of the studies to ensure they are successful;
- Write clinical trial notifications and investigational device exemptions for submission to regulatory bodies;
- Work with external institutions and clinical staff where necessary;
- Act as the point of contact for all external and internal agencies;
- The Research Nurse will analyse data based on trial results, interpreting research information, and creating detailed documentation using to inform clinical procedures;
- Monitor and track progress and obstacles during clinical trial, responding to day-to-day problems;
- Manage post-market surveillance/post market clinical follow-up activities for existing and new devices;
- Prepare manuals and present conclusions at conferences and seminars;
- Undertake any other reasonable duties as requested by the line manager;
Education & Qualifications
- Ideally degree educated or equivalent practical work experience
- Trained diabetes nurse with clinical background
- Anticipated to be a Senior Diabetes Specialist nurse band 7 or 8a
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