Which role is indispensable for daily functioning, scheduling, and adherence to GCPs at the site?

Answer

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC), also known under the title Study Coordinator, is absolutely critical for the seamless, day-to-day operational success of any investigative site. This role is the organizational hub, responsible for maintaining compliance, efficiency, and overall order within the trial activities at the site level. Their duties span the entire trial timeline, commencing with managing activities related to study start-up and obtaining ethics approval, moving through the logistical complexities of scheduling participant visits accurately, and concluding with facilitating necessary follow-up interactions after monitoring assessments. The CRC works diligently to ensure that the site’s execution strictly conforms to the established protocol, all regulatory requirements, and the governing principles of Good Clinical Practice (GCP).

Which role is indispensable for daily functioning, scheduling, and adherence to GCPs at the site?

Related Questions

Who holds ultimate responsibility for overall management and financing of a clinical trial?What primary responsibility does the Principal Investigator (PI) hold at each participating site?How does the Clinical Research Associate (CRA) typically differ from the Clinical Research Coordinator (CRC)?What statistical contributions does the Biostatistician make during the trial design phase?What is the primary function of the Quality Assurance (QA) Team regarding trial standards?Which role is indispensable for daily functioning, scheduling, and adherence to GCPs at the site?If a trial is multinational, who appoints the Principal Investigator (PI) for every participating site?Whose role centers on ensuring research drugs are administered safely and optimally?What is the primary responsibility of the Regulatory Specialist concerning study documentation?What contribution do Public and Patient Involvement (PPI) representatives offer the trial team?
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