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Clinical Trials Medical Officer

2 months ago

London, Greater London, United Kingdom Clerkenwell Health Full time

About Clerkenwell Health

Clerkenwell Health is a pioneering Research Organisation dedicated to conducting scientifically robust Clinical Trials through its collaborative Contract Research Organisation, extensive Site Network, and advanced Therapy Development Programme. Our focus is on enhancing the Mental Health and CNS research landscape, particularly in the realm of Psychedelic drug development.

Role Overview

Under the guidance of the Lead Clinician, the successful candidate will undertake both scientific/regulatory and clinical responsibilities. The scientific aspect will primarily involve consultancy and CRO functions, assisting clients in the development of their compounds in accordance with regulatory standards and trial design. The clinical responsibilities will center on providing exceptional patient care while executing efficient phase 1, 2, and 3 clinical trials.

Main Responsibilities

  • Scientific / Regulatory Duties:
    • Drafting clinical trial protocols and development plans.
    • Contributing to regulatory submissions.
    • Participating in scientific advisory meetings with regulatory bodies.
    • Engaging in advisory board meetings, steering committee meetings, data monitoring, and ethics committee meetings.
  • Clinical Duties:
    • Acting as co-investigator on clinical trial sites as needed.
    • Serving as a subject matter expert or medical monitor for the CRO when appropriate.
    • Supporting participant recruitment by fostering relationships with patient groups and healthcare professionals.
    • Conducting delegated screening and assessment activities with trial participants.
    • Performing clinical evaluations and investigations of participants as delegated.
    • Ensuring the medical wellbeing of participants during trials, with referrals to secondary or primary care as necessary.
    • Facilitating informed consent from prospective trial participants prior to any trial procedures.
    • Screening participants based on specific inclusion and exclusion criteria.
    • Building and maintaining positive relationships with sponsors, clients, and external experts.
    • Reporting serious adverse events/adverse events in accordance with protocols.
    • Ensuring compliance with trial protocols and documenting any deviations appropriately.

Qualifications and Skills

Essential:

  • MBBS degree.
  • Full GMC Registration with a License to Practise.
  • Formal training in Good Clinical Practice (GCP).
  • ILS ALS Certification.

Desirable:

  • Current GCP certification.
  • BA/BSc in a relevant field.
  • Additional research qualifications.

Skills and Competencies

Essential:

  • Understanding and interest in the clinical trials process, particularly in neuroscience and innovative drug treatments for mental health and CNS disorders.
  • Exceptional interpersonal skills with the ability to establish rapport with participants, colleagues, and clients.

Prior Experience:

  • Clinical experience, particularly in psychiatry, including conducting unsupervised clinical evaluations.
  • Experience in reviewing and interpreting research related to clinical trials.

Behavioral Traits:

  • Strong written and verbal communication skills.
  • Able to cultivate positive professional relationships and influence senior stakeholders.
  • Capable of conveying complex concepts related to mental health, neuroscience, and clinical trials to diverse audiences.
  • Skilled in balancing research and administrative responsibilities while meeting deadlines.
  • Proactive in assuming responsibility and making impactful decisions on projects.
  • Committed to ongoing innovation and personal development, including mentoring and training others.
  • Dedicated to personal growth and initiative in pursuing necessary training to enhance skills and contribute to the organization.

Additional Requirements

  • Willingness to travel as required for the role.