Principle Investigator/Senior Physician (Phase I/Early Stage)

Principle Investigator/Senior Physician (Phase I/Early Stage)

hVIVO

London, United Kingdom

Overview

The Principle Investigator (PI), at hVIVO is an experienced research physician who provides leadership and direction to the clinical staff during the conduct of a clinical study. A senior role within both the Volunteer Screening Department & Viral Challenge Unit, the PI provides input into the development and management of a clinical study, in addition to carrying out study specific medical duties and screening functions.

Working closely with the Clinical Site Management, other SI’s & the team of Investigators, the PI oversees the study subjects, participates in assessments for eligibility, medical case reviews and medically supervises subjects during screening, out patient studies and within the viral challenge unit. In addition, this requires working across the board with other clinical colleagues, the clinical operations team and project management team.

Main Responsibilities

  • Promote Good Clinical Practice (GCP) in the conduct of clinical studies by adhering to protocol requirements;
  • Oversee the medical management of subjects at screening, out-patient studies and within the viral challenge unit;
  • Oversee clinic personnel performing study specific tasks and procedures;
  • Provide medical input at all stages of the project lifecycle;
  • Provide leadership, training, mentoring and guidance to clinical staff in all aspects of trial conduct and project orientation so that staff perform their duties in compliance with GCP, local regulations, hVIVO SOPs and guidance;
  • Provide medical input into trial design, protocol and amendment development, subject informed consent, study logistics, and clinical study report preparation;
  • Facilitates a team environment to ensure h VIVO staff demonstratepositive, productive and effective working relationships both internally and externally;
  • Adequately, accurately, and legibly records information into subjects’ source document notes;
  • 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;
  • 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;
  • Build a strong understanding of virology and the medical implications as it relates to conducting studies using the human viral challenge model;
  • Develop and maintains a strong understanding of infectious disease and respiratory illness management as it applies to the conduct of clinical studies within the human viral challenge model.

Skills & Experiences

  • Medical Degree;
  • Current ALS/ACLS;
  • GMC Registration;
  • Fluency in English;
  • Phlebotomy & Cannulation skills;
  • Experience working within the UK health structure;
  • Post-foundation prescribing experience;
  • Experience as a study physician within a clinical reserach environment.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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