Clinical Research Coordinator (CRC)

Clinical Research Coordinator (CRC)

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.

Position Summary: The Clinical Research Coordinator will support the planning, execution, and closeout of clinical studies involving human subjects. This includes FDA-regulated drug and device trials, NIH-funded research, and investigator-initiated protocols. The CRC ensures compliance with California-specific regulatory frameworks, institutional policies, and federal guidelines (FDA, ICH-GCP, HIPAA). Experience in CRC in Liver/GI/Obesity studies preferred!

Key Responsibilities:

• Study Operations: Coordinate Phase I–IV clinical trials across multiple therapeutic areas. Prepare IRB submissions, amendments, and continuing reviews. Develop and maintain study documentation, SOPs, and case report forms. Schedule and conduct study visits, collect data, and ensure protocol adherence.
• Participant Management: Recruit, screen, and consent participants in accordance with CPHS and institutional HRPP standards. Educate participants on study procedures, risks, and rights. Monitor for adverse events and report per FDA and California Health & Safety Code §24170–24179.5.
• Regulatory & Compliance: Maintain audit-ready records and ensure GCP compliance. Handle protected health information (PHI) securely under California law. Liaise with sponsors, monitors, and regulatory bodies.
• Data & Budget Oversight: Enter and validate data in CTMS and EDC systems. Assist with budget development and financial tracking. Coordinate biospecimen collection, processing, and shipping.

Job Type: Full-time

Work Location: In person

Requirements:

• Education: Bachelor's degree in health sciences, biology, nursing, or related field (Master's preferred). Formal training in clinical research or regulatory affairs.
• Experience: 1–3 years of clinical research coordination experience, primarily in liver/GI/obesity studies. Familiarity with California IRB systems and CPHS protocols. Experience with FDA-regulated trials and NIH-funded studies.
• Skills: Strong organizational and time management abilities. Excellent verbal and written communication skills. Proficiency in CTMS, EDC, and IRB platforms (e.g., iRIS, OnCore). Ability to work independently and collaboratively across teams. Preferably bilingual in English/Spanish.