Smarter HR Solutions LLC
Clinical Research Coordinator (CRC)
Smarter HR Solutions LLC, Anaheim, California, United States, 92808
Job DescriptionJob descriptionJob Title: Clinical Research Coordinator (CRC)Job Type: Full-TimeJob Location(s): Los Angeles, CA / Anaheim, CA *This role is ONSITE* Job Salary: $57,000.00 - $62,000.00 per yearJob Schedule: M-F 40-hours/weekPosition SummaryThe 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).Key ResponsibilitiesStudy OperationsCoordinate 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 ManagementRecruit, screen, and consent participants in accordance with CPHS and institutional HRPP standardsEducate participants on study procedures, risks, and rightsMonitor for adverse events and report per FDA and California Health & Safety Code §24170-24179.5Regulatory & ComplianceMaintain audit-ready records and ensure GCP complianceHandle protected health information (PHI) securely under California lawLiaise with sponsors, monitors, and regulatory bodiesData & Budget OversightEnter and validate data in CTMS and EDC systemsAssist with budget development and financial trackingCoordinate biospecimen collection, processing, and shippingJob Type: Full-timeWork Location: In personRequirementsQualificationsEducationBachelor's degree in health sciences, biology, nursing, or related field (Master's preferred).Formal training in clinical research or regulatory affairs.Experience1-3 years of clinical research coordination experience.Familiarity with California IRB systems and CPHS protocols.Experience with FDA-regulated trials and NIH-funded studies.SkillsStrong 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.