Principle Investigator (Senior Physician, Clinical Trials)

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: