CRA 2
Core
Conduct clinical trial site monitoring and management to ensure studies adhere to protocols, GCP, and ICH guidelines.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Clinical research
Required skills
Site monitoring, subject recruitment management, protocol administration, regulatory compliance (GCP/ICH), TMF/ISF management, data query resolution
Preferred skills
Therapeutic knowledge, project management, financial management
Technologies
Microsoft Word, Excel, PowerPoint, laptop, iPhone, iPad
Responsibilities
Perform site monitoring visits (selection, initiation, monitoring, close-out), drive subject recruitment plans, administer protocol training, evaluate site quality and integrity, track regulatory submissions and enrollment, maintain TMF and ISF documentation, generate visit reports and action plans
Seniority
Senior, hands-on IC