Clinical Research Coordinator (CRC)
Smarter HR Solutions LLC•Orange, CA
•$32 - $35•Onsite
About The Position
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!
Requirements
- 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
Nice To Haves
- Preferably bilingual in English/Spanish
Responsibilities
- 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.
- 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
- Maintain audit-ready records and ensure GCP compliance
- Handle protected health information (PHI) securely under California law
- Liaise with sponsors, monitors, and regulatory bodies
- Enter and validate data in CTMS and EDC systems
- Assist with budget development and financial tracking
- Coordinate biospecimen collection, processing, and shipping
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
