Job Description
About the Role
This is an exciting opportunity to join the Research & Development Office at Great Ormond Street Hospital (GOSH) in collaboration with the UCL Institute of Child Health (ICH). The role has been developed to support high-quality clinical research in line with UK clinical trial regulations.
As a Clinical Trials Coordinator, you will play a key role in ensuring that all clinical research activities comply with Good Clinical Practice (GCP) standards and regulatory requirements. You will work closely with investigators, pharmacy teams, and research staff, offering both practical and administrative support across a range of clinical trials.
Your work will also involve interaction with key regulatory and governing bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), helping ensure that studies meet national standards and guidelines.
Key Responsibilities
1. Trial Set-Up and Preparation
- Support the Clinical Trials Manager in planning and coordinating study start-up activities
Prepare and maintain essential study documentation, including Trial Master Files and site files
Assist with regulatory and ethics submissions in line with UK frameworks
Ensure all study teams are appropriately trained and resourced before trial initiation
2. Trial Monitoring and Coordination
- Conduct site initiation visits and central monitoring activities
Verify that trial sites meet required standards, including staffing, facilities, and equipment
Ensure adherence to protocols, SOPs, and regulatory requirements
Develop and maintain monitoring plans based on risk assessments
Track progress and compliance across all participating sites
3. Trial Conduct and Oversight
- Work with pharmacy teams to verify investigational products before trial launch
Ensure all trial materials and documentation are in place and compliant
Support communication between stakeholders, including regulatory authorities and academic partners
Contribute to audits, inspections, and reporting processes
Working Environment
GOSH is committed to creating an inclusive, supportive, and diverse workplace. Staff are encouraged to engage with internal networks that promote equality, accessibility, and wellbeing. The organisation values diverse perspectives and aims to reflect the communities it serves.
Person Specification
Essential Qualifications
A degree in a science or biomedical-related field
ICH-GCP certification
Essential Experience
- Experience working in a clinical trials environment (NHS, university, or industry)
Knowledge of UK clinical trial regulations and governance
Practical experience in trial coordination, monitoring, or research processes
Understanding of NHS research structures and sponsor responsibilities
Desirable
- Experience in trial auditing or monitoring certification
Knowledge of pharmacovigilance
Familiarity with UK health research policy frameworks
Key Skills
- Strong communication and presentation abilities
Excellent organisational and time management skills
Proficiency in IT systems and databases
Ability to write clear, structured reports
Confidence working independently and within a team
Adaptability and proactive problem-solving
Capability to guide and support senior clinical staff
Additional Information
- This role may involve travel for multi-centre trials
Applicants requiring Skilled Worker visa sponsorship are welcome to apply
A Disclosure and Barring Service (DBS) check will be required
Important Notes
- Applications may close early if sufficient interest is received
Only candidates who clearly meet the criteria will be shortlisted
Early application is strongly encouraged