Gain insight into how inSeption Group’s Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites and acting as a “one-stop shop” for all activities related to clinical study sites.
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.