Senior Clinical Research Coordinator - Lead Trials

Proclinical Staffing; Chicago (IL); On-site; USD 41,000 - 52,000; Full time

Job summary

Proclinical Staffing is seeking a Senior Clinical Research Coordinator to independently manage complex trials in Chicago, IL. You will oversee study management, mentor staff, and ensure regulatory compliance while safeguarding participant safety.

Responsibilities include coordinating from initiation to close-out, data entry in EDC, and liaising with sponsors. CTMS/EDC proficiency and FDA/ICH-GCP knowledge are essential, with phlebotomy preferred.

Qualifications

• Hands-on experience as a Clinical Research Coordinator in a research site, hospital, or private practice.
• Proficiency in clinical trial management systems (CTMS) and EDC systems.
• Strong knowledge of clinical research regulations, FDA guidelines, and ICH-GCP standards.
• Phlebotomy skills and/or certification preferred.
• Excellent organizational, leadership, and critical thinking abilities.
• Strong verbal and written communication skills.
• Detail-oriented with a commitment to data accuracy, patient safety, and regulatory compliance.

Responsibilities

• Manage clinical trials from initiation to close-out, including high-complexity and high-enrollment studies.
• Supervise and mentor junior Clinical Research Coordinators, providing guidance and training.
• Recruit, screen, and consent study participants in accordance with study protocols.
• Dispense investigational products and monitor participant adherence to study requirements.
• Collect and process biological specimens, perform vital signs assessments, ECGs, and phlebotomy.
• Schedule and conduct participant visits and assessments as outlined in the protocol.
• Accurately document and enter data into electronic data capture (EDC) systems, resolving queries as needed.
• Maintain regulatory binders and ensure readiness for monitoring visits.
• Track and report adverse events, ensuring timely submission of serious adverse event (SAE) reports.
• Act as a liaison between sponsors, monitors, and referring physicians.

Skills

Clinical trial coordination

Regulatory compliance

FDA guidelines

ICH-GCP

Phlebotomy certification

Leadership

Communication

Data accuracy

Tools

CTMS

EDC

Job description

Proclinical Staffing is seeking a Senior Clinical Research Coordinator to independently manage complex trials in Chicago, IL. You will oversee study management, mentor staff, and ensure regulatory compliance while safeguarding participant safety.

Responsibilities include coordinating from initiation to close-out, data entry in EDC, and liaising with sponsors. CTMS/EDC proficiency and FDA/ICH-GCP knowledge are essential, with phlebotomy preferred.