FSP CRA 1 & CRA 2
Core
Conduct site monitoring visits and manage clinical trial sites to ensure adherence to study protocols, GCP, and ICH guidelines.
Role type
Clinical Research Associate (monitoring and site management)
Builds
Clinical trial data integrity and regulatory compliance for life sciences studies
Domain
Clinical research / Life sciences
Required skills
Site monitoring, subject recruitment tracking, protocol administration, regulatory compliance (GCP/ICH), TMF/ISF management, data query resolution, financial management, travel
Preferred skills
Bachelor's degree in scientific discipline or healthcare, therapeutic knowledge, Microsoft Office proficiency
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, generate visit reports and action plans, support site financial management
Seniority
Junior to Mid-level, hands-on IC
