Support patient visits and ensure a positive, safe participant experience.
Oversee patient recruitment efforts and maintain recruitment portals to meet enrollment targets.
Regulatory & Compliance
Communicate 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 Collaboration
Coordinate 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 Management
Partner 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.
Qualifications
Prior 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.
