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.
Main Responsibilities and Duties:
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 demonstrate positive, 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.
Key Skills:
- Medical Degere
- Current ALS/ACLS
- GMC Registration
- Fluency in English
- Phlebotomoy & Cannulation skills
- Experience working within the UK health structure
- Post-foundation prescribing experience
- Experience as a study physician within a clinical research environment
Skills Required
- Medical Degree
- Current ALS/ACLS
- GMC Registration
- Fluency in English
- Phlebotomy and Cannulation skills
- Experience working within the UK health structure
- Post-foundation prescribing experience
- Experience as a study physician within a clinical research environment
What We Do
hVIVO is a science-led, full-service early-phase contract research organisation (CRO) and the global leader in human challenge trials. The company provides end-to-end drug development services, from preclinical consultancy through to Phase III clinical trials. It operates an integrated ecosystem combining specialist clinical sites, advanced virology and immunology laboratories, and recruitment platforms like FluCamp to accelerate the path to clinical proof-of-concept for biopharmaceutical clients.
