Job summary
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.
Main duties of the job
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.
Maintaining the trial master files, setting up TMF systems and devising appropriate proformas specific to trial management.
Liaison with the various trial centres, ensuring that they are compliant with trial standard operating procedures, protocols and regulatory requirements, and that they are being kept informed about trial developments; (this involves site visits and monitoring.)
Produce regular reports regarding trial progress for general distribution as well as reports to the ethics committee, oversight committees and sponsor as required.
Facilitating Good Clinical Practice compliance in the trial.
Development and implementation of trial documentation e.g. data collection and monitoring forms, trial specific operating procedures.
Preparing clinical trial teams, and documentation for regulatory inspections; coordinating inspections
To set up and implement systems and procedures for the start up and monitoring of clinical research projects.
To act as liaison between external organisations and the Trust in the initiation, approval and management of clinical trials.
To act as a resource for researchers applying for regulatory approvals, advising and assisting with applications.
About us
Liverpool Women's NHS FT became part of NHS University Hospitals of Liverpool Group (UHLG) in November 2024, following the coming together with Liverpool University Hospitals NHS FT. UHLG was born from a shared aim to improve the care we provide to our patients.
UHLG is one of the largest employers in the region, with over 16,800 colleagues who are dedicated to caring for our communities - from birth and beyond. For the 630,000 people across Merseyside, UHLG is also their local NHS, providing general and emergency hospital care, alongside highly specialised regional services for more than two million people in the North West.
At Liverpool Women's Hospital, each year we deliver approximately 7,500 babies, carry out around 50,000 gynaecological inpatient and outpatient procedures, care for over 1,000 poorly and premature newborns, perform around 1,000 IVF cycles, and conduct over 4,000 genetic appointments.
We believe that this, along with a strong dedication to research and innovation, makes usthespecialist health provider of choice in Europe for women, babies and families.
For roles at Liverpool University Hospitals, visit their careers page.
UKVI guidelines prohibits sponsorship for all Band 2 posts. Guidelines state that many non-clinical posts are not eligible for sponsorship. Please use UKVI guidance on Skilled Worker Visas to determine your eligibility for sponsorship if you were to gain a conditional offer for this role.
https://www.gov.uk/skilled-worker-visa/your-job
Job description
Job responsibilities
Liaison with staff across the Trust informing them of trial activities going on in their departments and actively encouraging research collaborations.
Servicing trial committees - organising attendees, agendas, attending meetings, take and write up minutes where necessary.
Active participation in the trial oversight meetings, providing advice concerning trial regulatory and governance procedures.
Assist with the financial management of clinical trials, liaising with trial sponsors and finance ensuring financial records are kept up to date and contractual financial schedules are adhered to.
To ensure compliance with Trust RD&I standard operating procedures
Collecting case report forms/data and ensuring the completeness of trial data when necessary.
Investigating and locating missing data
Working with Clinical Trials Units in the development and management of clinical trial specific databases.
To liaise with departments across the Trust (including pharmacy and finance) to ensure all research projects are adequately planned and executed.
To liaise with pharmaceutical companies to facilitate commercial research collaboration.
Collate and report portfolio accrual data to the National database.
Visit the participating centres in the UK as needed to ensure good recruitment and record keeping (devising and assisting with trial recruitment drives).
Prepare ad-hoc reports and present details of trial progress at meetings as necessary.
Write trial promotional materials and organise continued trial promotion to prevent recruitment fatigue - e.g. newsletters, website, social media, awareness days etc.
Job description
Job responsibilities
Liaison with staff across the Trust informing them of trial activities going on in their departments and actively encouraging research collaborations.
Servicing trial committees - organising attendees, agendas, attending meetings, take and write up minutes where necessary.
Active participation in the trial oversight meetings, providing advice concerning trial regulatory and governance procedures.
Assist with the financial management of clinical trials, liaising with trial sponsors and finance ensuring financial records are kept up to date and contractual financial schedules are adhered to.
To ensure compliance with Trust RD&I standard operating procedures
Collecting case report forms/data and ensuring the completeness of trial data when necessary.
Investigating and locating missing data
Working with Clinical Trials Units in the development and management of clinical trial specific databases.
To liaise with departments across the Trust (including pharmacy and finance) to ensure all research projects are adequately planned and executed.
To liaise with pharmaceutical companies to facilitate commercial research collaboration.
Collate and report portfolio accrual data to the National database.
Visit the participating centres in the UK as needed to ensure good recruitment and record keeping (devising and assisting with trial recruitment drives).
Prepare ad-hoc reports and present details of trial progress at meetings as necessary.
Write trial promotional materials and organise continued trial promotion to prevent recruitment fatigue - e.g. newsletters, website, social media, awareness days etc.
Person Specification
Qualifications
Essential
- Educated to degree level in related discipline or demonstrable experience of working at the level
- Training in Good Clinical Practice requirements
- Evidence of continuing professional development
Desirable
- Project management qualification
Skills & Knowledge
Essential
- Research sponsorship / governance experience in an NHS environment
- Knowledge and understanding of clinical trials/research legislation
- Understanding of the management of clinical research in the NHS and the research regulatory processes in line with the HRA process
- Ability to understand medical and clinical trial terminology
- Ability to effectively manage and prioritise workload to meet stringent deadlines
- Knowledge of maintaining research activity databases, data collection management and reporting
Desirable
- Clinical trial monitoring
Experience
Essential
- Demonstrable expertise in the setting up of clinical trials / studies, experience in the necessary research processes
- Working in accordance with research specific guidelines, eg Good Clinical Practice, EU clinical trials directives etc
- Management of confidential data or records
- Working autonomously and as part of a multi-disciplinary team
Desirable
- Training facilitation skills
- Ability to liaise with national regulatory / funding bodies and agencies
Other
Essential
- Excellent communication and skills both written and verbal
- Excellent IT skills and demonstrable proficiency with MS Office applications including Word, PowerPoint and Excel
- Ability and willingness to work flexibility to meet the needs of the service
Person Specification
Qualifications
Essential
- Educated to degree level in related discipline or demonstrable experience of working at the level
- Training in Good Clinical Practice requirements
- Evidence of continuing professional development
Desirable
- Project management qualification
Skills & Knowledge
Essential
- Research sponsorship / governance experience in an NHS environment
- Knowledge and understanding of clinical trials/research legislation
- Understanding of the management of clinical research in the NHS and the research regulatory processes in line with the HRA process
- Ability to understand medical and clinical trial terminology
- Ability to effectively manage and prioritise workload to meet stringent deadlines
- Knowledge of maintaining research activity databases, data collection management and reporting
Desirable
- Clinical trial monitoring
Experience
Essential
- Demonstrable expertise in the setting up of clinical trials / studies, experience in the necessary research processes
- Working in accordance with research specific guidelines, eg Good Clinical Practice, EU clinical trials directives etc
- Management of confidential data or records
- Working autonomously and as part of a multi-disciplinary team
Desirable
- Training facilitation skills
- Ability to liaise with national regulatory / funding bodies and agencies
Other
Essential
- Excellent communication and skills both written and verbal
- Excellent IT skills and demonstrable proficiency with MS Office applications including Word, PowerPoint and Excel
- Ability and willingness to work flexibility to meet the needs of the service
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
