Clinical Research Associate - Sponsor Dedicated
Core
Perform site monitoring and management to ensure clinical studies are conducted per protocol and regulations, managing data integrity and site operations.
Role type
Clinical Research Associate (monitoring)
Builds
Clinical trial data and site compliance
Domain
Life sciences / Clinical research
Required skills
GCP/ICH guidelines knowledge, site monitoring, subject recruitment tracking, protocol administration, regulatory submission tracking, TMF/ISF management, documentation generation, financial management
Preferred skills
Bachelor's degree in scientific discipline or healthcare, CRA training completion, 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 to sites, evaluate site practice quality and integrity, track regulatory submissions and enrollment, manage Trial Master File and Investigator's Site File, generate visit reports and action plans, support site financial management
Seniority
Individual Contributor