Clinical Research Coordinator (CRC)

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