Director - DDC
Core
Ensuring rights and wellbeing of trial participants are protected and reported trial data are accurate, complete, and verifiable from source documents.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trials for pharmaceutical and life sciences clients
Domain
Clinical research / Pharmaceutical industry
Deliverable
client delivery
Required skills
Site relationship management, ICH GCP compliance, regulatory requirement understanding, participant recruitment, site monitoring, document preparation
Preferred skills
Time management, attention to detail, computer literacy
Technologies
None stated
Responsibilities
Build relationships with Principal Investigators, study coordinators, and pharmacists; collaborate with Regulatory teams on ethics and regulatory submissions; ensure participant recruitment targets are met; conduct monitoring visits (Site Selection, Initiation, Monitoring, Close Out, pharmacy visits) per ICH GCP
Seniority
Mid-level (CRA II: 6 months experience; CRA III: 2+ years experience)
