Job Description

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of dermatology clinical trials in accordance with study protocols, ICH-GCP guidelines, and regulatory requirements. The CRC will work closely with investigators, sponsors, CROs, and study participants to ensure the successful execution of clinical trials.

Our site conducts dermatologic clinical trials including Atopic Dermatitis, Psoriasis, Alopecia Areata, Hidradenitis Suppurativa, and Vitiligo. We collaborate with leading pharmaceutical sponsors such as AbbVie, Sanofi, Novartis, and Sun Pharmaceutical Industries, among others.

Essential Duties and Responsibilities

Study Coordination

• 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

Participant Management

• 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

Data and Documentation

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

Laboratory and Investigational Product

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

Sponsor and Regulatory Compliance

• 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

Job Tags

Full time, Work at office

Similar Jobs