Clinical Research Coordinator II
Core
Oversee clinical site activities, ensure patient safety and data integrity, and conduct clinical studies according to FDA/GCP and ICH regulations.
Role type
Clinical Research Coordinator II
Builds
Clinical trials and patient data
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical study execution, patient care, scheduling, informed consent, vital signs measurement, regulatory compliance (FDA/GCP/ICH), data recording, IRB coordination, waste disposal
Preferred skills
Independent work, attention to detail, problem solving, discretion, decision-making, negotiation, influencing, communication, organizational skills, computer proficiency
Technologies
Case report forms, EDC systems
Responsibilities
Conduct clinical studies per regulations, provide medical care to patients, schedule subject visits, perform study activities (consent, screening, vitals, ECGs), record patient data, manage IP accountability logs, report non-compliance, obtain/maintain IRB approval, attend site meetings, manage patient communications, log data on sponsor systems, maintain source documents
Seniority
Mid-level, hands-on IC
