Senior / Clinical Research Associate
Core
Perform site monitoring and management to ensure clinical studies are conducted per protocol and regulations, managing data integrity and site operations.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data and regulatory compliance for life sciences and healthcare clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site monitoring execution, GCP/ICH regulatory compliance, subject recruitment management, protocol administration, data quality evaluation, TMF/ISF documentation, financial management, travel management
Preferred skills
Therapeutic area knowledge, start-up phase support
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 data quality and regulatory adherence, track regulatory submissions and enrollment, maintain Trial Master File and Investigator's Site File, generate visit reports and action plans, manage site financials and invoices
Seniority
Mid-level, hands-on IC