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Principal Investigator (PI)
About This Role
The Principal Investigator (PI) will provide overall medical and scientific leadership for clinical trials, ensuring participant safety, regulatory compliance, data integrity and high‑quality trial delivery. This role involves close collaboration with sponsors, study teams and regulatory bodies, and hands‑on involvement in participant assessments and trial oversight.
Key Responsibilities
• Act as Principal Investigator in accordance with ICH‑GCP, MHRA regulations and study protocols.
• Provide medical and psychiatric oversight throughout the full trial lifecycle.
• Conduct and supervise participant assessments at screening, dosing and follow‑up visits.
• Ensure participant safety, including timely identification and reporting of adverse events and serious adverse events.
• Maintain oversight of protocol adherence, managing deviations and corrective actions as required.
• Ensure accurate, complete and contemporaneous documentation in source data and CRFs.
• Oversee investigational medicinal product (IMP) handling, storage and accountability.
• Provide leadership, training and supervision to clinical and research staff.
• Liaise with sponsors, CROs, monitors and auditors as required.
• Contribute to the development and refinement of clinical protocols and trial procedures.
What You'll Need
Essential Qualifications & Experience
• Medical degree (MBBS, MD or equivalent). • Full GMC registration with licence to practise in the UK. • Membership of a relevant Royal College (e.g. MRCPsych, MRCP or equivalent). • Prior experience acting as a Principal Investigator in clinical research. • Strong working knowledge of ICH‑GCP, MHRA regulations and research governance. • Experience in psychiatric or CNS‑focused clinical trials. • Excellent communication, leadership and interpersonal skills.
Desirable Experience
• Experience in psychedelic‑assisted therapy trials or novel mental health interventions.
• Familiarity with structured clinical assessment tools (e.g. MINI, CAPS‑5, C‑SSRS).
• Experience working with sponsors, CROs and multidisciplinary research teams.
What You'll Get
Location & Working Arrangements
This is a site‑based role requiring regular on‑site presence at trial locations (e.g. London/Doncaster/Sheffield), with some flexibility for remote collaboration where appropriate.
Why Join Clerkenwell Health
This role offers the opportunity to play a leading role in pioneering mental health research, contributing to the development of innovative treatments in a purpose‑driven, collaborative and forward‑thinking organisation.
About Clerkenwell Health
Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded clinical trials through its collaborative Contract Research Organisation, extensive Site Network and pioneering Therapy Development Programme. We focus on advancing Mental Health and CNS research, with particular expertise in supporting psychedelic drug development.
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