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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.
Job Description
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
Familiarise yourself with the latest developments in psychedelic-assisted therapies. This will not only enhance your understanding but also demonstrate your commitment to the field during interviews.
✨Tip Number 2
Network with professionals in the mental health and CNS research community. Attend relevant conferences or webinars to connect with potential colleagues and learn about current trends and challenges in the industry.
✨Tip Number 3
Prepare to discuss your previous experience as a Principal Investigator in detail. Be ready to share specific examples of how you've ensured compliance with ICH-GCP guidelines and managed clinical trials effectively.
✨Tip Number 4
Showcase your leadership skills by highlighting any mentoring or training experiences you've had with clinical staff. This is crucial for the role, so be prepared to discuss how you foster collaboration and maintain high standards.
We think you need these skills to ace Principal Investigator (PI)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience as a Principal Investigator, particularly in mental health or CNS therapeutic areas. Emphasise your familiarity with ICH-GCP guidelines and clinical research regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving mental health outcomes through research. Mention specific experiences that demonstrate your leadership skills and commitment to ethical research conduct.
Highlight Relevant Skills: In your application, clearly outline your communication and interpersonal skills, especially your ability to liaise with sponsors and CROs. Include any experience with psychometric tools like MINI or CAPS-5.
Prepare for Interviews: Anticipate questions related to your experience in clinical trials and your approach to ensuring compliance with GCP. Be ready to discuss how you foster collaboration within teams and manage participant care.
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 in mental health or CNS therapeutic areas, highlighting specific projects where you ensured compliance and integrity.
✨Emphasise Leadership Skills
This role requires strong leadership abilities. Share examples of how you've successfully supervised and mentored clinical staff in past roles. Discuss your approach to fostering a collaborative team environment and how you handle challenges within a team setting.
✨Prepare for Ethical Discussions
Given the nature of psychedelic-assisted therapies, be ready to engage in discussions about ethical research conduct and informed consent processes. Familiarise yourself with the IRB/Ethics Committee review processes and be prepared to articulate your understanding of these critical aspects.
✨Demonstrate Communication Skills
Excellent communication is key in this role. Practice articulating complex medical concepts clearly and concisely. Be prepared to discuss how you liaise with sponsors, CROs, and site teams, showcasing your interpersonal skills and ability to build relationships.
