Clinical Trial Manager

Job Summary

Imperial College London has an outstanding reputation for excellence in medical teaching and research that is rated in the top 10 universities worldwide.

We are looking for an enthusiastic experienced Clinical Trial Manager to work within the Centre for Psychedelic Research and Addiction Research team within the Division of Psychiatry. These research centres conduct psychopharmacological research using experimental medicine, clinical trials and brain imaging (MRI, EEG) techniques to identify novel targets and assess the therapeutic potential of new treatments. The Centre for Psychedelic Research is primarily focused on investigating the mechanisms of psychedelic compounds for a range of disorders including addiction, whilst the Addiction Research team is focused on novel treatments in substance dependence, notably heroin/opioid addiction.

Duties & Responsibilities

In his role, you will work with the research team to deliver a 3-year funded NIHR award which is investigating whether psilocybin therapy is a safe and effective way of promoting abstinence in individuals who have recently detoxified from opioids. The trial is a phase IIa placebo-controlled, randomised, proof of concept trial to investigate the feasibility, safety, and efficacy of psilocybin therapy in opioid use disorder (OUD).

• Stage-1; a dose escalation phase to determine the most safe, effective, and tolerable (single, oral) psilocybin dose
• Stage-2; continuation phase to further test the dose of psilocybin identified in Stage 1 to assess feasibility, safety and clinical outcomes (opioid use/relapse) in a larger group of individuals
• This trial will be hosted by the Imperial Clinical Research Facility, recruiting participants from NHS and non-NHS (third sector) drug and alcohol services with whom we have established links.

You will be responsible for all aspects of trial management. This will include involvement and coordination of study set-up, in close liaison with Dr Paterson and Dr Erritzoe. Duties will include leading on the development of trial documentation, regulatory submissions, monitoring the progress and performance of the trial and recruitment from participant identification centres, ensuring efficient recruitment and reliable data collection. This will be achieved through implementing/adapting established procedures to ensure the studies are conducted in accordance with contractual agreements, trial protocol, trial-specific processes and systems, SOPs, regulatory and ethical requirements and ICH-GCP guidelines, as well as delivered to time and within budget constraints. You will have close interaction with the participant-facing staff including the Research Assistant, Post-doctoral Research Associate, Trial medic and therapist.

Essential

• BSc or equivalent in a biomedical/scientific field
• Proven clinical trial/project management experience gained in experimental medicine, phase II and/or phase III randomised trials of an investigational medicinal produce and have proven experience of conducting clinical trials of Investigational Medicinal Products (CTIMP) including data collection.
• Working knowledge of the current EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trial.
• Evidence of preparing regulatory and ethics submissions, writing/amending protocols, patient information sheets, case report forms (CRF) /electronic CRF, and other relevant trial management documentation.

Further Information

This post is based at the Hammersmith Campus and is full-time until 17 March 2027.

Should you require any further details on the role please contact:

Dr Louise Paterson l.paterson@imperial.ac.uk or Dr David Erritzoe at d.erritzoe@imperial.ac.uk

Closing date: 15^th April 2024

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