Job Description

This specialist role focuses on early phase CF trials, working alongside the existing CTAP Trial Coordinator and integrating into the local clinical and research teams to improve trial access for the CF community.

The postholder will work closely with:

Local CF Clinical and Research Teams - to coordinate and deliver early phase CF trials within the Trust.



CTAP Trial Coordinator - to ensure alignment and collaboration across early and later phase trials.



CTAP Programme Team (Cystic Fibrosis Trust) - for strategic guidance, reporting, and network-wide coordination.

Other CTAP Early Phase Centres and Affiliate Sites - to facilitate referrals, share best practices, and support national trial delivery.

Research & Development Departments - to ensure compliance with governance and regulatory requirements.



Trial Sponsors and CROs - to support trial setup, feasibility, and ongoing delivery.



Patients and Families - to provide information, support, and facilitate participation in clinical trials.



Training and Education Leads - to deliver mentorship and training to other CTAP centres preparing for early phase trial readiness

Key responsibilities include:

Supporting the delivery of early phase CF clinical trials within the CTAP Early Phase Sub-Network.



Optimising use of the CTAP Patient Identification Centre (PIC) model.



Facilitating research referrals in collaboration with other CTAP Centres, Affiliate Centres, and CF units.



Leading training, mentorship, and education initiatives to help other CTAP centres become 'phase 1 ready'.



Assisting with later phase CF trials locally during quieter periods.

Contributing to non-CF early phase trials to support professional development and broaden early phase trial experience.



This post is based within the Royal Brompton Cystic Fibrosis (CF) Clinical Trials Department, a multidisciplinary team of clinicians, academics, allied health professionals, and administrative staff. Led by Professors Davies, Simmonds, and colleagues, the adult and paediatric CF centres conduct internationally recognised, multicentre interventional and observational studies across all age groups. The department plays a key role in early phase research through its involvement in the CF Trusts CTAP Early Phase Sub-Network (https://www.cysticfibrosis.org.uk/research/clinical-trials/clinical-trials-accelerator-platform), a specialist group of centres established by the Cystic Fibrosis Trust to lead early phase CF trials across the UK. With CF care advancing rapidly and new treatments emerging, access to clinical trials is increasingly vital. CTAP supports trial sponsors and CF centres in the setup and delivery of studies across a network of 20 centres, including Guy's & St Thomas' NHS Trust. Based near the vibrant King's Road in Chelsea, this role offers excellent opportunities for collaboration and professional development within a dynamic clinical and research environment.



We encourage and support applicants in applicable career progression as a clinical research practitioner/research nurse including attendance at courses, seminars and conferences.



Communication & Coordination



Act as the primary contact for research teams and clinical colleagues, ensuring smooth trial delivery.



Liaise with internal and external stakeholders, including the CTAP Programme Team, trial sponsors, and CF centres.



Communicate complex and sensitive information to patients and carers, offering support and guidance.



Attend site initiation visits, manage trial approvals, and report serious adverse events.



Promote CF trials at meetings and contribute to team discussions and updates.



Patient Care & Trial Delivery



Independently assess and recruit patients, manage study protocols, and ensure accurate data collection.



Conduct health assessments (e.g. spirometry, ECG, sample collection) and administer study drugs.



Maintain documentation to GCP and Trust standards, and support monitoring visits.



Policy & Service Development



Draft and maintain study documentation (SOPs, CRFs) and support protocol development.



Monitor recruitment and retention, addressing issues with the CTAP national team



Ensure compliance with research governance and relevant legislation.



Stay updated on regulatory changes and contribute to service improvements.



Resource Management



Support feasibility assessments and portfolio expansion.



Coordinate CF research projects, monitor progress, and manage documentation systems.



Identify recruitment barriers and liaise with relevant teams to resolve them.



Manage equipment procurement and facilitate audits and inspections.



People Management



Oversee daily trial operations and coordinate multidisciplinary staff involvement.



Lead training and mentorship to support CTAP centres becoming 'phase 1 ready'.



Ensure staff are trained and delegated appropriately; support induction of new team members.



Information Management



Use multiple data platforms to manage trial data accurately and efficiently.



Oversee data entry, verification, and reporting; troubleshoot system and data issues.



Manage archiving and ensure compliance with data protection and IT policies.



Coordinate quarterly metric reporting to the CTAP Coordinating Team.



Research & Development



Lead audits and implement improvements based on governance standards.



Apply learning from existing studies to enhance future trial delivery.

Collaborate with clinical teams to develop services and promote research impact.



Other Duties



Be available for occasional night shifts and weekend cover.

Undertake other duties appropriate to the role and grade as required.