Clinical Research Coordinator

Key ResponsibilitiesStudy Coordination & OversightManage clinical trials from study start-up through close-out.Ensure compliance with ICH-GCP guidelines, FDA regulations, and study protocols.Maintain audit-ready study files and regulatory documentation at all times.Collaborate with the PI and research team to ensure protocol adherence and high-quality data collection.Maintain up-to-date research calendars aligned with investigator schedules.Clinical Procedures & Patient CarePerform study-related clinical procedures, including:PhlebotomyEKGsVital signsSupport patient visits and ensure a positive, safe participant experience.Oversee patient recruitment efforts and maintain recruitment portals to meet enrollment targets.Regulatory & ComplianceCommunicate with Institutional Review Boards (IRBs) to ensure appropriate oversight and approvals.Respond promptly to sponsor and CRO queries and action items.Maintain research binders and essential documents in audit-ready condition.Ensure temperature-controlled storage areas are properly maintained, including calibration and temperature logs.Ensure all research staff training is current and compliant with study and regulatory requirements.Sponsor & Monitor CollaborationCoordinate and schedule Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).Support feasibility assessments and engage with pharmaceutical and device sponsors regarding new study opportunities.Coordinate batch shipments in alignment with clinic workflow and staff availability.Team Collaboration & Data ManagementPartner with CRCs and research assistants to ensure timely data entry and query resolution.Ensure accurate, complete, and timely documentation across all trials.Maintain strong cross-functional communication to support study efficiency and compliance.QualificationsPrior experience as a Clinical Research Coordinator required.Strong knowledge of ICH-GCP, FDA regulations, and IRB processes.Proficiency in performing clinical procedures (phlebotomy, EKGs, vital signs).Excellent organizational skills with strong attention to detail.Ability to manage multiple studies in a fast-paced environment.Strong communication and problem-solving skills.Experience working with sponsors, CROs, and monitors.