Lead Clinical Research Coordinator

Job Summary

Lead Clinical Research Coordinator, a part-time position responsible for managing and coordinating clinical trial activities, ensuring compliance with protocols and regulations.

Key Responsibilities

• Independently conduct and manage assigned clinical trials in accordance with study protocols and regulatory guidelines
• Implement and coordinate all aspects of trials including subject recruitment, data entry, and regulatory document collection
• Prepare for and lead monitoring visits, audits, and inspections while managing adverse events and protocol deviations

Required Qualifications, Training, and Education

• Minimum 4-5 years of experience managing Phase II-III clinical trials as the lead coordinator
• Bachelor's degree required; clinical credential or Master's degree is a plus
• GCP Certification required; CCRC or CCRP certification strongly preferred
• Demonstrated mastery of ICH/GCP guidelines and FDA regulations
• Bilingual in English and Spanish required