Site Management And Clinical Monitoring
Source: inSeption Group
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.