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Driving Innovation Together: Join Us in Transforming Clinical Research

At Top One Research Group, we’re on a mission to advance medical science by forging meaningful partnerships and delivering high-quality research outcomes. Our commitment to collaboration goes beyond project timelines; we work closely with Sponsors, CROs, and medical experts to streamline clinical trial processes and bring life-changing treatments to patients. With expertise across a diverse range of therapeutic areas, our skilled team prioritizes data integrity, patient safety, and research efficiency at every phase.

Join us in pioneering new medical solutions that empower communities and improve lives. Explore our current studies, learn about our tailored approach, and discover how partnering with Top One Research Group can elevate your clinical research journey.

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We are seeking quality physicians, to be part our team in the this incredible journey

  • Writer: William Muro
    William Muro
  • Sep 5, 2023
  • 1 min read

Core Responsibilities of the Principal Investigator: Accountable for the successful completion of the study. • Personally conduct or supervise investigation • Follow protocol- ensuring inclusion and exclusion criteria are met, only make changes after notifying the sponsor unless subject at risk • Ensure all persons assisting with the study are informed of obligations • Inform subjects that drugs are being used for investigational purposes • Ensure informed consent, IRB review, approval, and reporting • Report to sponsor adverse events; read and understand the IB • Maintain adequate and accurate records and make them available for inspection • Ensure initial and continuing review by an IRB and report all changes to research and unanticipated problems involving risks to subjects, not make any changes without IRB approval except where necessary to eliminate immediate hazards

Eligibility Requirements: Sponsors or networks are required to select only “investigators qualified by training and experience as appropriate experts to investigate the drug”. An MD is not necessary.

If clinical investigator “is a non-physician, a qualified physician (or dentist when appropriate) should be listed as a sub investigator, responsible for all trial-related medical (or dental divisions).


Other Requirements: PI must understand: a) Adherence to Code of Federal Regulations b) Knowledge of Clinical Investigator regulations c) Understanding of Clinical Investigator responsibilities No investigator may participate in an investigation until they provide the sponsor with a completed, signed Statement of Investigator, Form FDA 1572


 
 
 

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