Senior Clinical Research Coordinator

2 weeks ago

Orange, CA, United States Smarter HR Solutions LLC Full time
Job Description
***Please note: This position is onsite and not remote. Candidates must be based in the Orange, CA area, as relocation assistance is not provided. Only individuals authorized to work in the U.S. will be considered.***

Job description

Job Title: Senior Clinical Research Coordinator (Liver Trials)

Job Type: Full-Time On-Site

Job Location: Orange, CA

Job Salary: $90,000-$100,000 per year (based on experience)

Industry: Clinical Research Hepatology Phase I-IV Trials

About Us:

We're a fast-paced, compliance-driven research clinic specializing in liver disease trials-from NASH and cirrhosis to hepatocellular carcinoma. Our team partners with leading sponsors and CROs to deliver high-quality, audit-ready data and compassionate patient care.

Position Overview:

This is an on-site position in Orange, CA, and applicants must reside within a commutable distance of 50 miles or less or be able to independently relocate. THIS IS NOT A REMOTE POSITION.

We're seeking a Senior Clinical Research Coordinator (CRC) with hands-on experience in liver-focused clinical trials. You'll lead study execution, regulatory coordination, and patient engagement across multiple protocols.

MUST HAVE - Experience in CRC in Liver/GI/Obesity studies

MUST HAVE - Regulatory experience

MUST HAVE - Fluency in Spanish

Key Responsibilities
• Coordinate Phase I-IV liver trials, including screening, enrollment, and follow-up
• Manage regulatory submissions (IRB, CPHS), source documentation, and AE reporting
• Oversee biospecimen handling and lab coordination
• Maintain CTMS and EDC systems (REDCap, Medidata, etc.)
• Mentor junior CRCs and support cross-functional study teams

Requirements

Qualifications

• 3-5+ years of CRC experience in liver/hepatology trials
• Strong knowledge of FDA, ICH-GCP, and HIPAA regulations
• Proficiency in CTMS, EDC platforms, and protocol adherence
• Excellent communication and documentation skills
• Bilingual (Spanish/English) preferred
• Familiarity with California specific regulations

Certifications
• GCP Training (Required)
• HIPAA & Human Subjects Protection (Required)
• CPHS Compliance Training (Required)
• CCRC (Certified Clinical Research Coordinator) (Preferred)
• CCRP (Certified Clinical Research Professional) (Preferred)

Benefits
• Competitive salary + performance bonuses
• Health, dental, and vision coverage
• Paid training and certification support
• Career growth in a high-impact research setting

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