Clinical Research Coordinator
About The Position
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.
Requirements
- Educational background in biology, science, or health-related field
- 1–3 years of clinical research experience preferred
- 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
Nice To Haves
- Dermatology research experience highly desirable
- Bilingual (English/Spanish) preferred
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
