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Clerkenwell Health
Central London, United Kingdom (hybrid)
26 days ago
Clerkenwell Health
Central London, United Kingdom
(hybrid)
Preferred
26 days ago
Job Type
Full-Time
Job Duration
Indefinite
Salary - Currency
Pounds Sterling
Salary - Type
Yearly Salary
Job Function
Other

Description

Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of Clinical Trials of psychedelic treatments and psychedelic-assisted therapy using its collaborative Contract Research Organisation, extensive Site Network, and leading Therapy Practitioner Training Programme. 

This role will involve oversight of the medical and psychiatric evaluation and management of subjects at screening and throughout their participation in clinical trials for psychedelic-assisted psychotherapies for mental health conditions, including dosing sessions and referrals to GP or specialist services if required. 

The successful candidate may also have the opportunity to be involved in other trial-related, contract research organisation (CRO), and training programme related activities.

Main duties and accountabilities

1.     Promote Good Clinical Practice (GCP) in the conduct of clinical studies by adhering to protocol requirements.

2.     Oversee the medical and psychiatric evaluation and management of subjects at screening and throughout their participation in clinical trials for psychedelic-assisted psychotherapies for mental health conditions, including dosing sessions and referrals to GP or specialist services if required.

3.     Ensure all trial-related procedures are conducted in accordance with trial protocols, reporting and recording any protocol deviations as appropriate.

4.     Ensure serious adverse events / adverse events are reported to the PI appropriately.

5.     Oversee clinic personnel performing study specific tasks and procedures.

6.     Provide medical and psychiatric input at all stages of the trial lifecycle.

7.     Provide leadership, training, mentoring and guidance to clinical staff in all aspects of trial conduct so that staff perform their duties in compliance with GCP, and the trial protocol.

8.     Facilitate a team environment to ensure Clerkenwell Health staff demonstrate positive, productive and effective working relationships both internally and externally.

9.     Adequately, accurately, and legibly records information into subjects’ source document notes.

10.  Review the accuracy, completeness, legibility and timeliness of case report form (CRF) completion, to ensure that CRFs accurately reflect subject source records, or any discrepancies are explained.

11.  Oversee the proper use and storage of the IMP and/or NIMP, including the dispensation and administration of the product to subjects, and product accountability.

12.  Complete psychometric/ structured interview assessment activities with trial participants



Requirements

Skills & Experience

Essential:

1.     MRCPsych

2.     Current ILS or ALS (can be obtained following appointment to the role)

3.     At least 6 months experience as a study physician within clinical research environment

4.     GCP certification (can be obtained following appointment to the role) 

5.     GMC full registration with licence to practise

6.     Fluency in English

7.     Experience working within UK health systems

Desirable:

1.     Experience with psychometric rating scales e.g. MINI, CAPS-5, C-SSRS

Job ID: 73234923

Please refer to the company's website or job descriptions to learn more about them.

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