Clinical Research Associate, Site Management - Italy
Core
Perform monitoring and site management to ensure clinical study sites conduct trials per protocol and regulations.
Role type
Clinical Research Associate (Site Management)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech studies
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
GCP/ICH guidelines knowledge, site monitoring execution, subject recruitment planning, protocol administration, TMF/ISF management, data query resolution, financial management, documentation creation
Preferred skills
CRA certification, prior monitoring experience, therapeutic knowledge
Technologies
Microsoft Word, Excel, PowerPoint, laptop, iPhone, iPad
Responsibilities
Conduct site monitoring visits (selection, initiation, monitoring, close-out), drive subject recruitment plans, administer protocol training, evaluate site quality and adherence, track regulatory submissions and enrollment, manage TMF and ISF documentation, generate visit reports and action plans, support site financial management
Seniority
Individual Contributor