Participant Recruitment & Retention: Identifies, screens, and recruits eligible subjects; obtains informed consent.
Study Coordination: Schedules patient visits, conducts study procedures, and ensures protocol adherence.
Data Management: Collects, records, and manages source data; completes Case Report Forms (CRFs) and resolves queries.
Regulatory Compliance: Maintains regulatory binders, submits documents to IRB, and reports adverse events.
Lab/Specimen Processing: Collects, processes, and ships laboratory samples.
Investigational Product Management: Manages storage, dispensing, and tracking of study medication/devices.
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