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Clinical Research Coordinator (CRC)

Smarter HR Solutions

  • Orange, California
  • 13 days ago

    Highlights

    The CRC ensures compliance with California-specific regulatory frameworks, institutional policies, and federal guidelines (FDA, ICH-GCP, HIPAA). This includes FDA-regulated drug and device trials, NIH-funded research, and investigator-initiated protocols.

    Numbers & Facts

    LocationOrange, California

    Description

    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


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