Job description Job Title: Clinical Research Coordinator (CRC) Job Type: Full-Time Job Location(s): Orange, CA *This role is ONSITE* Job Salary: $32-$35/hour ($66,560.00 - $72,800.00 per year) Job Schedule: M-F 40-hours/week 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 Qualifications 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