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St Thomas Westminster Bridge Road London

Senior Clinical Trials Facilitator - Study Set up Specialist

Guy's and St Thomas' NHS Foundation Trust
Health & Care
Health & Care
£38,488/Year
Full-time
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Description

Location
St Thomas Westminster Bridge Road, London

Hours
Full Time (hours not specified)

Salary
£38,488 per annum

About the Role
The Senior Clinical Trials Facilitator will play a key role in supporting clinical trials through site qualification, selection, feasibility, trial set up, study management, and research governance. You will work closely with Trial Sponsors, Clinical Research Organisations, Principal Investigators, Pharmacy departments, and other clinical research staff to ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and regulatory requirements.

Key responsibilities include:
- Conducting site qualification activities, including assessing pharmacy qualifications, capacity, and capability.
- Providing assurance to Sponsors, R&D, and King’s Health Partners Clinical Trials Office (KHP CTO) regarding pharmacy resources.
- Collaborating with Pharmacy Clinical Trials Managers to maintain research resources.
- Creating and maintaining essential documentation such as standard operating procedures.
- Engaging with KHP-CTO and R&D teams on site selection, study costing, and Clinical Trials Agreements.
- Undertaking National Costing Value Reviews (NCVR) on behalf of Pharmacy.
- Supporting feasibility assessments and issuing full approvals for studies.
- Managing trial set up activities including creating Pharmacy Site Folders, facilitating electronic prescription platforms, drafting trial-specific pharmacy procedures, and ensuring regulatory approvals.
- Coordinating training and delegation of duties for study pharmacy personnel.
- Acting as a liaison between clinical research teams, sponsors, CROs, and support departments during study management.
- Supporting IMP management at site level including shipments, reporting deviations, and communication with sponsors.
- Providing governance support and acting as the pharmacy specialist contact within the R&D Office.
- Maintaining up-to-date knowledge of NHS R&D management, GCP, MHRA guidance, NIHR and HRA publications, and contract developments.
- Travelling between sites and organisations as required to liaise with researchers and departments.

This role requires a solution-focused approach, excellent communication skills, and the ability to work collaboratively across multiple teams to ensure the successful delivery of clinical trials within the Trust.

Requirements

Experience
- Proven experience in clinical trials facilitation, particularly in pharmacy-related site qualification and trial set up.
- Experience working with Trial Sponsors, CROs, and clinical research teams.
- Familiarity with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and regulatory compliance.
- Experience in managing Investigational Medicinal Products (IMP) and clinical trial pharmacy procedures.
- Ability to interpret and translate clinical study documents into trial-specific pharmacy procedures.

About you
- Strong organisational and communication skills with the ability to liaise effectively with multiple stakeholders.
- Solution-focused and proactive in addressing challenges during site qualification and trial set up.
- Detail-oriented with the ability to maintain and create essential documentation.
- Ability to work independently and as part of a multidisciplinary team.
- Willingness to travel between sites and external organisations as required.

Qualifications
- Relevant qualifications or experience in clinical trials facilitation, pharmacy, or related healthcare research fields.
- Knowledge of NHS R&D governance and clinical trial regulations.
- Training or experience in electronic patient record systems (e.g., EPIC) and sponsor-specific systems is desirable.
- Commitment to ongoing professional development and staying current with regulatory guidance and best practices.

Expiry date: 04/08/2026
Senior Clinical Trials Facilitator - Study Set up Specialist
Company:
Guy's and St Thomas' NHS Foundation Trust
Salary:
£38,488/Year
Job Type:
Full-time
Location:
St Thomas Westminster Bridge Road London