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Posted August 23, 2026

Clinical Research Coordinator (CRC)

Smarter HR Solutions LLC
Orange, CA, US Full Time
90000USD - 100000USD per year

Job Description

Job 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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