Clinical Research Associate / Senior - FSP
Core
Managing assigned clinical trial investigator sites from activation through database lock to ensure patient safety and quality study execution.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance for pharmaceutical sponsors
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical trial methodologies, ICH/GCP, FDA regulations, site monitoring, AE/SAE monitoring, audit management
Preferred skills
Oncology therapeutic experience, Vaccines, Internal Medicine, Infectious Diseases
Technologies
None stated
Responsibilities
Ensure proper conduct of clinical trials in accordance with Study Monitoring Plan and applicable laws; Manage operational aspects for implementation of clinical trial activities at assigned investigator sites; Interface with the study team, vendors and assigned investigator sites; Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit; Serve as a point of contact for audit conduct and drive Audit Observation CAPA development
Seniority
Senior, hands-on IC
