What are the responsibilities and job description for the Clinical Research Coordinator (CRC) position at Smarter HR Solutions LLC?
Job description
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).
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
Work Location: In person
Requirements
Education
- Bachelor’s degree in health sciences, biology, nursing, or related field (Master’s preferred).
- Formal training in clinical research or regulatory affairs.
- 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.
- 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
Salary : $66,560 - $72,800