Clinical Research Coordinator

TidalSense is a respiratory technology company with a mission to transform the diagnosis, monitoring and management of chronic respiratory conditions, such as asthma and COPD. The company has ambitions to enable a population-scale change in respiratory care through global deployment of its technologies. TidalSense has just launched a first-of-its-kind AI-driven (software medical device) diagnostic test for COPD which uses the company's unique, patented, sensor technology embedded in the N-Tidal device.

We are seeking a clinical research coordinator with strong project management and organisational skills to drive our ambitious evidence generation programme. We are at an exciting phase in our journey as we transition from a start-up to a scale-up. You will be joining a passionate, socially-motivated and multi-disciplinary team covering engineers, scientists, clinicians, designers, product and usability specialists. This is a unique opportunity for a driven and autonomous individual to develop and manage clinical studies that will deliver impact in the real world and change people's lives. We are seeking someone who is comfortable working in a fast-paced, agile, and diverse team environment, and who is also committed to our mission to revolutionise respiratory medicine.

Job Purpose

To manage the initiation and running of our medical device clinical studies, and improve the systems and processes we use to ensure their success.

Key Duties And Responsibilities

• Facilitating and coordinating live projects, including:
• Putting together project plans
• Keeping progress trackers and risk registers updated
• Diarising and facilitating regular project meetings
• Maintaining TidalSense assets / stock used at clinical sites
• Reporting on key project ‘healthchecks', including:
• Monitoring actual study recruitment rates vs expectation
• Conducting regular assessments of data quality
• Tracking user and device errors and patterns of device use
• Liaising with other TidalSense departments on project performance and requirements
• Keeping budget tracking and forecasts updated (and visible to Finance)
• Keeping stock forecasts updated (and visible to Supply Chain)
• Escalating issues and findings concerning study progress, compliance and efficiency
• Delivering site onboarding, including training new users on TidalSense devices
• Providing first-line support to resolve user issues on live projects, including:
• Supporting sites with logging support requests & issues, incidents, complaints and feedback , and suggestions using TidalSense's Helpdesk software
• Ensuring prompt escalation of issues to the relevant internal stakeholders and project managing resolution to promote good site experience
• Supporting the wider Clinical Operations team, including contributing to project charters, protocols, governance paperwork and other pre-initiation documents
  
  

Requirements

Skills & competencies

Essential:

• Strong organisational and project management skills, with excellent attention to detail
• Ability to think creatively and find pragmatic solutions to operational and logistical problems
• Excellent written and verbal communication and people skills; able to communicate complex concepts to different stakeholders
• Ability to consistently deliver to deadlines and manage competing priorities
• Positive approach to challenges and willingness to learn and develop
• Good time keeping, punctuality and professional conduct
• Collaborative approach to teamwork and hands-on mentality
• Proficient with Microsoft Word and Excel
  
  
  

Qualifications & Experience

Essential:

• Experience of managing or delivering clinical research studies or trials
  
  

Desirable:

• Experience working within a quality management system (ISO 13485 or ISO 9001)
• Experience working with medical device products, or experience working within a healthcare organisation
• Qualified healthcare professional with clinical experience
• Experience of protocol / bid / grant / scientific writing
  
  
  

Other Requirements

• Legally eligible to work in the UK without sponsorship. Please note that we are open to sponsoring colleagues to move from a unsponsored visa to a Skilled Worker Visa once they have passed their probationary review
• Will need to be able to work in person in the Cambridge office at least 3 days per week
• Will need to be willing and able to travel to clinical sites within the UK (and occasionally to sites in Europe) approximately 4 days per month on average
  
  
  

Note to Applicants

• We read all applications carefully - including your free-text answers - in evaluating your application. Please make sure you spend some time answering these questions carefully
• Please answer questions truthfully. Dishonesty is fundamentally against our values
• We appreciate that some candidates may hesitate to apply because they may feel that they might not meet all of the required criteria or be competitive enough. If this is you, please don't shy away from applying - we would really like to hear from you!
  
  
  

CLOSING DATE FOR APPLICATIONS: Sunday 11th May 2025

Benefits

• Flexible working hours to support your work preferences
• Hybrid working as per requirements above
• Beautiful award-winning Cambridge UK office stocked with quality drinks & snacks
• Work from abroad for 1 week per year
• Buy / sell up to 5 days annual leave
• Generous individual personal development budget + dedicated development days
• Mental Health support: wellbeing support and free 24/7 access to qualified counsellors and advisors
• Wellness budget
• Coaching and mentoring
• Team events and celebrations
• 25 days annual leave + 8 public holidays
• Pension: TidalSense contributes 5% of qualified earnings (actively looking to increase this)
• Annual performance-based bonus
• Discretionary share options scheme
  
  
  

Salary £35,000 - £45,000 (depending On Experience)

TidalSense operates a fair pay structure to ensure our colleagues are paid equitably and competitively for their skill, expertise and experience. Successful candidates will be offered this role at the appropriate grade, based on both their resume experience and our judgement of their performance level through the assessment process.