Clinical Research Coordinator II

Coordination of study visits and study procedures. Maintaining regulatory and study documentation. Creating source documents, study specific training in accordance with study protocols and Good Clinical Practice (GCP) guidelines. Perform participant pre-screening, screening, recruitment, enrollment, and informed consent. Conduct study visits and clinical procedures as required by protocol. Maintain accurate and complete source documentation and study records. Develop study-specific tools including source documents, visit checklists, and training materials. Ensure maintenance and organization of regulatory documentation, including IRB submissions, continuing reviews, protocol amendments, and reporting requirements. Monitor and report adverse events, serious adverse events, and protocol deviations in accordance with institutional and sponsor requirements. Perform data collection, entry, management, and quality control checks to ensure accuracy and completeness of study data. Resolve data queries and maintain research databases (e.g., REDCap or equivalent systems). Work closely with Principal Investigators to coordinate and execute all aspects of multiple clinical trials. Collect, process, and ship biological specimens according to protocol requirements and ensure proper chain of custody and storage conditions. Maintain study supplies, inventory, and equipment required for research operations. Communicate effectively with study sponsors, IRB, clinical teams, laboratories, and other stakeholders to ensure study compliance and efficiency. Participate in study initiation, monitoring visits, audits, and close-out activities as required. Responsibilities are subject to change based on departmental priorities, study requirements, regulatory obligations, and operational needs.