Clinical Trials Coordinator

The role of the Clinical Trials Coordinator will assist the Research Delivery Manager in the effective management of RD&I governance. The post holder will be responsible for supporting investigators with the smooth running of clinical trials in accordance with the appropriate quality systems, regulations and best practice. The role will predominantly focus on clinical research that is sponsored by the Trust.

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• Compile and manage clinical trial and ethical regulatory applications and substantial amendments.
  
• Act as the central point of contact and administrative lead for clinical trial study teams, maintaining good communication between team members and the various trial committees.
  
• Maintain trial master files (TMFs), set up TMF systems, and devise appropriate proformas specific to trial management.
  
• Liaise with trial centres to ensure compliance with trial SOPs, protocols and regulatory requirements; inform them about trial developments (this may include site visits and monitoring).
  
• Produce regular reports regarding trial progress for distribution and for ethics committees, oversight committees and sponsor as required.
  
• Facilitate Good Clinical Practice (GCP) compliance in the trial.
  
• Develop and implement trial documentation (e.g., data collection and monitoring forms, trial-specific standard operating procedures).
  
• Prepare clinical trial teams and documentation for regulatory inspections; coordinate inspections.
  
• Set up and implement systems and procedures for the start up and monitoring of clinical research projects.
  
• Act as liaison between external organisations and the Trust in the initiation, approval and management of clinical trials.
  
• Advise and assist researchers with regulatory approvals and liaise with staff across the Trust about trial activities to encourage research collaborations.
  
• Service trial committees — organise attendees, agendas, attend meetings, and take/write up minutes where necessary.
  
• Participate in trial oversight meetings, providing advice on trial regulatory and governance procedures.
  
• Assist with the financial management of clinical trials, liaising with trial sponsors and finance to ensure financial records are up to date and contractual financial schedules are adhered to.
  
• Ensure compliance with Trust RD&I standard operating procedures.
  
• Collect case report forms/data and ensure the completeness of trial data; investigate and locate missing data.
  
• Work with Clinical Trials Units in the development and management of clinical trial databases.
  
• Liaise with departments across the Trust (including pharmacy and finance) to ensure research projects are planned and executed.
  
• Liaise with pharmaceutical companies to facilitate commercial research collaboration.
  
• Collate and report portfolio accrual data to the National database.
  
• Visit participating centres in the UK as needed to support recruitment and record keeping; assist with trial recruitment drives.
  
• Prepare ad-hoc reports and present trial progress at meetings as necessary.
  
• Write trial promotional materials and organise ongoing trial promotion (e.g., newsletters, website, social media, awareness days) to prevent recruitment fatigue.
  

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• Experience in coordinating clinical trials and supporting regulatory submissions.
  
• Understanding of Good Clinical Practice (GCP) and relevant regulatory requirements.
  
• Strong organisational, communication and administrative skills; ability to coordinate multiple stakeholders and trial committees.
  
• Experience with trial master file management and data collection/monitoring tools.
  
• Ability to produce regular trial progress reports and support inspections and audits.
  
• Financial awareness related to trial budgeting and sponsorship coordination.
  
• Willingness to travel to trial sites as needed and to work within Trust policies and procedures.
  

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• Post adverts are open to employees of hospitals within the Liverpool Women’s NHS Foundation Trust and you should confirm your employment within your application form.
  
• Note: Under current Home Office Immigration Rules we are currently unable to offer right to work visa sponsorship for Band 2 and 3 roles with a salary of less than £25,000 per annum as they do not meet the UK Visas & Immigration criteria.
  
• Liverpool Women’s NHS Foundation Trust is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults.
  
• DBS cost information: the cost (£26.40 standard or £54.40 enhanced) is recovered via salary deductions after commencement.
  
• Equality and diversity: the Trust is committed to equality and promoting a diverse workforce; flexible working arrangements will be considered.
  
• If you need adjustments in the application process, contact the Trust’s recruitment team.
  
• Band details, organisational history, and information about the Trust’s group structure may be included as context for applicants.
  
• UKVI guidance on sponsorship and visas applies where relevant to eligibility for conditional offers.