Clinical Research Coordinator (CRC)

Job description

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).

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
  

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.
  

• 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.