Clinical Research Coordinator II

Position Summary

Coordinate all aspects of clinical trials with strict adherence to ICH-GCP guidelines, protocols, and regulatory requirements from study initiation through completion.

Essential Responsibilities

Study Coordination

• Coordinate patient involvement for complex and/or multiple studies under supervision
• Organize research information and clinical trial documentation
• Schedule and oversee data collection activities
• Monitor and report research data to maintain quality and compliance

Patient Care & Safety

• Educate potential participants and caregivers on protocol-specific details and expectations
• Perform safety and efficacy assessments per protocol (vital signs, EKGs, blood draws, other assessments)
• Review and report adverse events, protocol deviations, and unanticipated problems appropriately
• Observe subjects and assist with data analysis and reporting

Regulatory & Administrative

• Perform administrative and regulatory duties related to studies
• Ensure site receives accurate information and supplies from sponsors (source documents, protocols, scales, approvals, contacts)
• Participate in protocol development activities
• Assist Clinical Trial Manager with oversight of vendors, accounting, regulatory compliance, and quality

Team Support & Development

• Assist CTM in planning, creating processes, and training staff
• Provide mentorship to junior coordinators
• Support recruitment efforts and client satisfaction initiatives

Required Qualifications

• High school diploma or equivalent required; Bachelor's degree preferred
• Must demonstrate mastery of Clinical Research Coordinator I responsibilities
• 2-3 years of experience in clinical research or medical field preferred
• Knowledge of Federal regulations protecting human subjects and governing clinical trial conduct
• Strong understanding of ICH-GCP guidelines

Preferred Qualifications

• CCRC (Certified Clinical Research Coordinator) certification
• Experience coordinating multiple concurrent protocols
• Previous Phase I-IV clinical trial experience