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Research Physician in Clinical Trials

2 months ago

London, Greater London, United Kingdom Clerkenwell Health Full time

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. The focus of Clerkenwell Health is on enhancing the Mental Health and CNS research landscape, particularly in the realm of Psychedelic drug development.

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 activities, assisting clients in the development of their compounds in alignment with regulatory standards and trial design. The clinical responsibilities will center on providing exceptional patient care while efficiently executing phase 1, 2, and 3 clinical trials.

Key Responsibilities

  • Scientific / Regulatory Duties:
    • Draft clinical trial protocols and development strategies.
    • Contribute to regulatory submissions and documentation.
    • Participate in scientific advisory meetings with regulatory bodies.
    • Engage in advisory board, steering committee, data monitoring, and ethics committee meetings.
  • Clinical Responsibilities:
    • Act as co-investigator on clinical trial sites when appropriate.
    • Serve as a subject matter expert or medical monitor for the CRO as needed.
    • Support participant recruitment efforts by building relationships with patient groups and healthcare professionals.
    • Conduct delegated screening and assessment activities with trial participants.
    • Perform clinical evaluations and investigations of participants as delegated.
    • Ensure the medical wellbeing of participants during trials, referring to secondary or primary care as necessary.
    • Obtain fully informed written consent from prospective trial participants prior to any trial procedures.
    • Screen participants based on specific inclusion and exclusion criteria.
    • Foster positive relationships with sponsors, clients, and external experts.
    • Report serious adverse events and adverse events in accordance with protocols.
    • Ensure all trial-related procedures adhere to established protocols, documenting any deviations as necessary.

Qualifications and Experience

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 build rapport with participants, colleagues, and clients.

Prior Experience:

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

Behavioral Traits:

  • Excellent 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.
  • Able to manage the demands of research and administrative tasks effectively.
  • Proactive in assuming responsibility and making impactful decisions on projects.
  • Committed to ongoing innovation and personal development, including mentoring and training others.
  • Dedicated to self-improvement and actively seeking training opportunities to enhance skills and contribute value to the organization.

Additional Requirements:

  • Willingness to travel as required for the role.