Clinical Research Associate / Senior - FSP - Remote
Core
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trials for pharmaceutical sponsors
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical trial methodologies, ICH/GCP, FDA and local country regulations, Site monitoring, AEs and SAEs monitoring, Audit conduct
Preferred skills
Oncology experience, Vaccines experience, Internal Medicine experience, Infectious Diseases experience
Responsibilities
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices; 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 and checks
Seniority
Senior, hands-on IC