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- Tasks: Lead psychedelic clinical trials, ensuring compliance and participant care.
- Company: Clerkenwell Health is a pioneering Research Organisation focused on mental health and psychedelic drug development.
- Benefits: Enjoy a collaborative work environment and the chance to make a real impact in mental health research.
- Why this job: Join a team dedicated to innovation and compassion in improving mental health outcomes.
- Qualifications: Medical degree, GMC registration, and experience as a Principal Investigator required.
- Other info: Weekly travel to Doncaster is necessary; strong communication skills are essential.
The predicted salary is between 43200 - 72000 £ per year.
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 experienced Principal 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 are Compassion, Collaboration, Innovation , and Integrity . 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.
Principal Investigator (PI) employer: Clerkenwell Health
Contact Detail:
Clerkenwell Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Investigator (PI)
✨Tip Number 1
Network with professionals in the mental health and clinical research fields. Attend relevant conferences or seminars where you can meet potential colleagues and learn more about the latest developments in psychedelic-assisted therapies.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines related to psychedelic research. Understanding ICH-GCP and local laws will not only enhance your knowledge but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your previous experience as a Principal Investigator in detail. Highlight any specific challenges you faced and how you overcame them, particularly in mental health or CNS therapeutic areas, as this will showcase your leadership skills.
✨Tip Number 4
Showcase your passion for improving mental health outcomes. Be ready to articulate why you are interested in psychedelic-assisted therapies and how your values align with those of Clerkenwell Health, particularly around compassion and collaboration.
We think you need these skills to ace Principal Investigator (PI)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience as a Principal Investigator, particularly in mental health or CNS therapeutic areas. Emphasise any relevant clinical trials you've led and your familiarity with ICH-GCP guidelines.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving mental health outcomes through research. Mention specific experiences that align with the role's requirements, such as your knowledge of psychedelic-assisted therapies and your leadership skills.
Highlight Relevant Qualifications: Clearly list your medical qualifications, including your GMC registration and any memberships like MRCPsych or MRCP. This will demonstrate your credibility and readiness for the role.
Prepare for Interviews: Anticipate questions related to your experience with clinical trials and your understanding of regulatory compliance. Be ready to discuss how you would ensure adherence to GCP and manage participant care throughout the study lifecycle.
How to prepare for a job interview at Clerkenwell Health
✨Showcase Your Expertise
As a Principal Investigator, it's crucial to demonstrate your in-depth knowledge of clinical research regulations and ICH-GCP guidelines. Be prepared to discuss your previous experiences and how they align with the responsibilities outlined in the job description.
✨Emphasise Leadership Skills
Highlight your ability to lead and mentor clinical staff effectively. Share examples of how you've fostered a collaborative team environment in past roles, as this aligns with Clerkenwell Health's core values of Compassion and Collaboration.
✨Prepare for Ethical Discussions
Given the focus on psychedelic-assisted therapies, be ready to discuss ethical considerations in clinical trials. Familiarise yourself with informed consent processes and how you ensure participant safety and compliance with ethical standards.
✨Demonstrate Communication Skills
Excellent communication is key for liaising with sponsors and site teams. Practice articulating complex concepts clearly and concisely, and prepare to discuss how you handle difficult conversations or conflicts in a professional setting.
