Clinical Research Associate, Full Service
Core
Perform monitoring and site management to ensure clinical studies are conducted per protocol and regulations.
Role type
Clinical Research Associate (Full Service)
Builds
Clinical trial data and regulatory compliance
Domain
Life sciences / Healthcare
Required skills
GCP/ICH guidelines knowledge, site monitoring, subject recruitment management, protocol administration, data query resolution, TMF/ISF management, 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, 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 site financial management
Seniority
Individual Contributor