Physician / Clinical Research / Florida / Locum or Permanent / Principal Investigator Job
Company: Excel Medical Clinical Trials LLC
Location: Boca Raton
Posted on: May 10, 2022
The 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 & Responsibilities
Evaluate patient eligibility for a clinical trial as per
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
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
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
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
Keywords: Excel Medical Clinical Trials LLC, Boca Raton , Physician / Clinical Research / Florida / Locum or Permanent / Principal Investigator Job, Healthcare , Boca Raton, Florida
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