Clinical Trials Monitor

Chelsea and Westminster Hospital NHS Foundation Trust; Greater London; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading NHS Trust in Greater London is seeking a Clinical Trials Monitor. The successful candidate will be responsible for planning and organising monitoring activities for clinical trials, ensuring adherence to ICH GCP guidelines and maintaining documentation accuracy. Strong organisational and interpersonal skills are essential, as the role requires complex communication with investigators. The position offers diverse experiences in clinical trial management and contributes to improving research processes.

Qualifications

• Experience in clinical trial monitoring with ICH GCP knowledge.
• Ability to manage multiple clinical trials simultaneously.
• Excellent communication skills to provide complex advice.

Responsibilities

• Plan and organise monitoring activities for clinical trials.
• Initiate and oversee monitoring plans for Trust sponsored trials.
• Ensure all trial documentation is in place prior to commencement.
• Maintain IMP drug accountability and traceability.

Skills

Clinical trial monitoring

Knowledge of ICH GCP guidelines

Organisational skills

Interpersonal skills

Analytical skills

Tools

Electronic data capture systems

Job description

The Clinical Trials Monitor post is based in the Research & Development Department with a focus to lead on the monitoring of clinical trials sponsored by Chelsea and Westminster Hospital NHS Foundation Trust (CWFT).

The post holder will report directly to the Regulatory Compliance Manager and work with them for study set up, routine monitoring and the close out of both clinical trials of investigational medicinal products (CTIMPs) and non-CTIMPs on behalf of CWFT.

The Post holder will support the CWFT Sponsor Team and Chief Investigators by monitoring studies in accordance with the monitoring plan, protocol, regulatory requirements, SOP’s and GCP. Conducting on-site, remote and central monitoring visits as outlined in the monitoring plans and writing reports, tracking non-compliances, and escalating findings following the visits. The post holder will be the main point of contact for sites hosting CWFT studies and will also support the CWFT Sponsor Team in improving sponsorship processes and monitoring strategy.

To be responsible for the monitoring, conduct, progress review and documentation of Trust sponsored clinical trials by reviewing sponsor and site trial documents and performing source document verification (SDV) in accordance with ICH GCP guidelines.

Chelsea and Westminster Hospital NHS Foundation Trust is one of England's top-performing and safest trusts. We operate two main acute hospital sites—Chelsea and Westminster Hospital and West Middlesex University Hospital—along with award-winning clinics across North West London.

Our nearly 7,500 staff care for a diverse population of 1.5 million, providing full clinical services, including maternity, A&E, and children’s services, plus specialist HIV and sexual health clinics. The Care Quality Commission rates us Good in safety, effectiveness, care, and responsiveness, and Outstanding in leadership and resource use.

We continually invest in our facilities, including a £30m expansion of critical care at Chelsea and Westminster and an £80m Ambulatory Diagnostic Centre at West Middlesex.

We welcome applications for flexible working arrangements, accommodating requests where possible to support our staff and patient needs.

The Trust is committed to equality and welcomes applications from all, regardless of background. Adjustments can be made for disabled candidates. Early application is advised as vacancies may close once sufficient applications are received. If you haven’t heard from us within three weeks of the closing date, your application was likely unsuccessful. Employment is subject to a six-month probationary period.

Some roles may require weekend shifts at multiple sites.

Responsibilities

• Plan and organise monitoring activities, ensuring monitoring plans are reviewed and approved prior to trial initiation.
• Initiate and oversee monitoring plans for Trust sponsored clinical trials.
• Ensure that all appropriate medication manufacture, supply and release documentation is in place before the trial commences.
• Adhere to trial related SOP’s, especially the recording, reporting and tracking of Serious Adverse Events and Adverse Reactions.
• Coordinate trial initiation visits before any research activity commences, reviewing facilities and obtaining signed Investigator agreements.
• Maintain IMP drug accountability and traceability, and conduct end of trial reporting according to regulation.
• Assist in preparing for external audits and inspections, ensuring the Trust meets legal requirements for trial sponsorship.
• Review trial protocols using risk assessment tools and compile individual monitoring plans commensurate with trial scale for sign-off by the Clinical Trial Project Manager.
• Review monitoring reports from non-CWFT sites in conjunction with the trial Chief Investigator, ensuring compliance requirements are maintained.
• Provide complex advice to investigators and trial managers on monitoring, conduct, progress and documentation.
• Arrange meetings with research teams to monitor clinical trial activity, resolve data queries and provide written reports on monitoring findings and progress.
• Escalate key monitoring findings to the CWFT Project Managers for review and action.
• Maintain a report of monitoring findings for trial audit and updated CWFT research training.
• Write reports, follow up letters to sites following site visits and monitor and record follow up of action points resulting from those visits.
• Utilise electronic data capture systems for monitoring activity where applicable.
• Provide training to Trust staff on CWFT SOP’s and compliance requirements, and support workshop sessions relating to trial monitoring and data management.
• Assist the CWFT Project Management teams in collating data on CWFT clinical trial activity and coordinate trial monitoring activity with researchers and other applicable departments of the Trust.
• Review monitoring practice and recommend any changes or developments to the CWFT Project Management team.
• Provide cover for colleagues as appropriate, assist in producing ad‑hoc reports and undertake any other duties requested as appropriate to the job level.
• Support the Research Department’s audit program by conducting and following up audits allocated by the Research Clinical Studies Officer.

Qualifications

• Experience in clinical trial monitoring, knowledge of ICH GCP guidelines, and familiarity with CTIMP and non‑CTIMP studies.
• Strong organisational and analytical skills with the ability to manage multiple clinical trials simultaneously.
• Excellent communication and interpersonal skills, able to provide complex advice to investigators and research teams.
• Proficiency in using electronic data capture and monitoring systems.

This advert closes on Tuesday 27 Jan 2026.