Site Management And Clinical Monitoring

Source: inSeption Group
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Our experienced Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site.

Overview of Expertise

  • Act as primary point-of-contact with investigational site personnel:

    • Relationship building to ensure efficient conduct of study activities
    • Communication of study information between the Project Manager, Executive Management, Sponsor, and the investigational sites, as appropriate
  • Responsible for all aspects of clinical monitoring, including site-specific study deliverables:
    • Protocol and GCP training and compliance, including variance tracking and escalation
    • Subject oversight, including safety, visit compliance, sample management, and completion of protocol-specific assessments
    • Study data oversight, including source document vs EDC review and query resolution
    • Inspection-readiness of site files
    • Regulatory document collection, including site staff updates
    • Site process improvements and corrective/preventative actions
    • Site supplies management based on enrollment, including investigational product, lab kits, etc.