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Job Description
Job Overview
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Essential Functions
Complete required therapeutic, protocol, and clinical research training.
Gain experience in study procedures with support from senior clinical staff.
Conduct site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
Train sites on protocol requirements and maintain ongoing communication.
Assess site compliance and escalate quality issues as needed.
Track study progress: regulatory submissions, enrollment, CRFs, and data queries.
Maintain TMF/ISF documentation per GCP/ICH and local regulations.
Support study start-up activities.