Position SummaryThe PI assumes full responsibility for a clinical trial, including the oversight and ethical conduct of the study, maintaining integrity of the study design, and direction of the research team to ensure research is conducted in accordance with the local and national laws and regulations, including applicable FDA regulations, GCP, ICH guidelines, HIPAA, and all policies and procedures of the Sponsor, CRO and Site.
Duties & ResponsibilitiesEvaluate patient eligibility for a clinical trial as per protocol.Review and discuss study protocols and obtain (or delegate) informed consents from patients.
Meet with patients during designated study visits to perform assessments, including physical examinations and data collection.
Review and interpret laboratory results, EKGs and other diagnostic and safety assessments as required per study protocol.
Monitor all safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medications as per protocol, and un-blinding requests.
Use proper medical judgment in the interpretation and decision-making as it relates to the investigational study.Review, approve and ensure timely reporting of eCRFs, protocol deviations and Serious Adverse Events (SAE).
Ensure accurate documentation of study-related procedures.Ensure proper use and storage of Investigational Product.Ensure prompt reporting all unanticipated problems or injuries to IRB, Sponsor, or delegated representative.
Meet with FDA, IRB, Sponsors, CROs, or their delegated representatives as needed throughout the study.Review and discuss any medical or protocol-related concerns with medical monitors.
Attend Investigator Meetings and other study-related meetings.Review and approve Clinical Study Agreements.Work with Sub-investigator(s), Clinical Research Coordinators, and key study personnel in overseeing the execution of study protocols.
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