Clinical Research Coordinator - Unblinded - Contract

About this role

Responsibilities

• Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
• Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
• Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
• Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/exclusion criteria.
• Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.