Lead Study Coordinator

We are looking for a Lead Study Coorindator to join our team and support our two sites in West London!

Who are we?

Clerkenwell Health is a pioneering leader in clinical research, specialising in scientifically grounded clinical trials in the Mental Health and CNS space, with a focus on psychedelic drug development. Our unique approach integrates a collaborative Contract Research Organisation (CRO), an extensive Clinical Research Facility (CRF) network, and a leading Therapy Development Program. We are seeking an experienced Lead Study Coordinator to lead the study coordination.

The Role

We are seeking a Lead Study Coordinator to oversee and coordinate the successful delivery of Phase I-III Clinical Trials. This role requires a strong understanding of clinical research processes, data management, and regulatory requirements. You will be responsible for ensuring trials are conducted to the highest standards, in line with ICH-GCP guidelines and Clerkenwell Health's Standard Operating Procedures (SOPs).

What will the role entail?

• Serve as the primary point of contact for clinical trials, liaising with study sponsors, CROs, internal departments, and research teams.
• Manage the set-up, initiation, and ongoing coordination of clinical studies, ensuring timelines and milestones are met.
• Oversee the maintenance of Investigator Site Files and essential documentation, ensuring they remain inspection-ready.
• Process trial amendments and inform finance teams of any cost implications.
• Ensure all adverse events, protocol deviations, and incident reports are documented and resolved according to study protocols.
• Monitor case report form completion, data locks, and patient recruitment progress.
• Attend project meetings, investigator conferences, and audit preparations.
• Supervise the Study Coordinator team across multiple sites, managing work allocation and providing support as needed.
• Assist senior managers with recruitment, onboarding, and training of new clinical trial staff.
• Encourage the sharing of best practices within the team and ensure administrative processes run efficiently.

What will you need to succeed?

• A degree in a science or health-related field
• Strong knowledge of UK Clinical Regulations and ICH-GCP
• Experience leading complex clinical trials, from writing protocols to data management
• Confident managing teams across multiple sites and driving performance
• Excellent communication skills, you can liaise with sponsors, senior managers, and site staff with ease
• Proactive problem-solver who thrives under pressure and can juggle priorities
• Experience with psychedelic drug development or mental health research would be advantageous
• Financial management experience would be advantageous

What will the interview process be?

There will be an initial screening call with the recruiter, a first stage with the Head of Clinical, a team interview finished with a panel presentation style interview

Is this the role for you?

This is a unique and exciting opportunity to take on a lead role in an innovative company at the forefront of psychedelic drug research. If you are an experienced clinical research leader with a passion for quality and driving the success of cutting-edge trials, we’d love to hear from you.

At Clerkenwell Health, we value Compassion, Collaboration, Innovation, and Integrity. If you’re passionate about making a difference in mental health research and align with our values, we’d love to hear from you!