CRA 2
Core
Perform site monitoring and management to ensure clinical studies are conducted per protocol and regulations.
Role type
Clinical Research Associate (monitoring)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Clinical research
Required skills
GCP knowledge, ICH guidelines, site monitoring, subject recruitment tracking, protocol administration, data query resolution, TMF/ISF management, visit reporting, financial management
Preferred skills
Bachelor's in scientific discipline or healthcare, therapeutic knowledge, Microsoft Office proficiency, mobile device usage
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 integrity, track regulatory submissions and enrollment, maintain Trial Master File and Investigator's Site File, submit visit reports and action plans, support financial management and invoice retrieval
Seniority
Entry-level to Junior, hands-on IC