Who are we?
Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials using its collaborative Contract Research Organisation, extensive Site Network and leading Therapy Development Programme. We focus on supporting Mental Health and CNS research, with particular expertise in psychedelic drug development.
The role
We are seeking an experiencedPrincipal Investigator (PI)to lead the medical oversight and delivery of psychedelic-assisted psychotherapy clinical trials. The post holder will play a critical leadership role in ensuring the highest standards of clinical and research integrity, regulatory compliance, and participant care throughout the study lifecycle.
What will the role entail?
- Serve as the Principal Investigator on psychedelic clinical trials, fulfilling all responsibilities outlined under ICH-GCP, including governance, oversight, pharmacovigilance, and reporting.
- Promote and ensure adherence to Good Clinical Practice (GCP) and all protocol requirements across trial operations.
- Oversee the medical and psychiatric evaluation of participants at screening, dosing, and follow-up stages; manage referrals to GP or specialist services as needed.
- Ensure full protocol compliance during trial procedures; identify and document any deviations appropriately.
- Accurately report serious adverse events (SAEs) and adverse events (AEs) to the trial sponsor and Chief Investigator.
- Supervise and mentor clinical staff involved in study-specific assessments and procedures.
- Provide clinical leadership, training, and ongoing mentorship to trial staff to uphold GCP and protocol standards.
- Foster a positive and collaborative team environment within Clerkenwell Health and with external stakeholders.
- Ensure accurate and complete documentation in source notes and clinical trial case report forms (CRFs).
- Oversee the use, storage, dispensing, and accountability of Investigational Medicinal Products (IMP) and non-IMPs.
- Monitor and review the completion of psychometric and structured interview assessments conducted with trial participants.
- Maintain current knowledge of psychedelic-assisted therapies, relevant clinical protocols, and therapeutic innovations.
What will you need?
- To be able to travel to Doncaster at least once a week
- Medical degree (e.g., MBBS, MD)
- GMC full registration with licence to practise
- MRCPsych, MRCP, or equivalent medical college membership
- Previous Experience as a Principal Investigator (PI)
- Experience in mental health or CNS therapeutic areas would be advantageous
- In-depth knowledge of clinical research regulations (FDA, EMA, MHRA), ICH-GCP guidelines, and local/international laws
- Excellent communication and interpersonal skills for liaising with sponsors, CROs, and site teams
- Familiarity with ethical research conduct, informed consent, and IRB/Ethics Committee review processes
- Sound risk management and safety practices
- Experience with rating tools such as MINI, CAPS-5, and C-SSRS
What will the process be?
An initial screening call with the recruiter followed by a 2 stage interview process over Teams.
Is This the Role for You?
At Clerkenwell Health, our core values areCompassion, Collaboration, Innovation, andIntegrity. If you're passionate about improving mental health outcomes through research and ready to take a lead role in pioneering psychedelic-assisted therapies - we’d love to hear from you.
