Job Description

Key Responsibilities

Study Coordination & Oversight

• Manage 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 Care

• Perform study-related clinical procedures, including:
• Phlebotomy
• EKGs
• Vital signs
• 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.

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