Clinical Research Coordinator

• Coordinate clinical trials from start-up through close-out
• Review study protocols and ensure site compliance
• Prepare and maintain regulatory documents and study binders
• Assist with IRB submissions and continuing reviews

• Recruit, screen, and consent eligible study participants
• Schedule and conduct study visits according to protocol
• Perform clinical assessments and collect study data
• Provide patient education regarding study participation

• Create and maintain accurate source documentation
• Enter data into Electronic Data Capture (EDC) systems
• Resolve data queries promptly
• Ensure ALCOA+ data integrity standards

• Obtain, process, prepare, and ship laboratory specimens
• Maintain investigational product accountability logs
• Ensure proper storage and temperature monitoring

• Communicate effectively with sponsors and CROs
• Prepare for and support monitoring visits, audits, and inspections
• Maintain compliance with ICH-GCP, FDA, and HIPAA regulations
• Adhere to site SOPs and quality standards

Qualifications

Education

• Educational background in biology, science, or health-related field

Experience

• 1–3 years of clinical research experience preferred
• Dermatology research experience highly desirable

Knowledge & Skills

• Strong understanding of ICH-GCP and FDA regulations
• Excellent organizational and multitasking skills
• Strong attention to detail
• Professional and compassionate patient interaction skills
• Proficiency with EDC systems and Microsoft Office
• Bilingual (English/Spanish) preferred