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Research Nurse

Website intellin_ Gendius

*CVs / Expressions of interest can be returned to hello@gendius.co.uk

BENEFITS

 

Basic annual salary £40 – 50k but could be flexible for the right candidate
Annual Leave 25 days a/l + shutdown between Christmas and New Year (which is in addition to the a/l allowance)
Pension Statutory pension allowance
Probation Period 6 months
Share options After completion of the 6 month probation period an option to join the company’s EMI share ownership scheme will be offered

 

 

JOB DESCRIPTION

Key Role Responsibilities

 

  • Assist with compiling and submitting grant applications;
  • Review and advise on the clinical content within the Intellin® platform;
  • Liaison with users of the app to understand clinical needs and queries
  • 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;
  • 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;
  • 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;
  • 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;

 

PERSON SPECIFICATION

Education/Qualifications/Experience

  • 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