Sr. CRA
Core
Conduct site monitoring and management to ensure clinical studies adhere to protocols, regulations, and sponsor requirements.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for life sciences studies
Domain
Clinical research / Life sciences
Required skills
Site monitoring (selection, initiation, monitoring, close-out), subject recruitment management, protocol administration, GCP/ICH regulatory compliance, TMF/ISF documentation, data query resolution, financial management, travel logistics
Preferred skills
Mentoring/training new CRAs, audit/inspection experience, therapeutic area knowledge
Technologies
Microsoft Word, Excel, PowerPoint, laptop, iPhone, iPad
Responsibilities
Perform site monitoring visits, drive subject recruitment plans, administer protocol training, evaluate site quality and integrity, track regulatory submissions and enrollment, maintain Trial Master File and Investigator's Site File, generate visit reports and action plans, support start-up phases, manage site financials
Seniority
Senior, hands-on IC
