Smarter HR Solutions, LLC · 6 days ago
Regulatory Specialist
Orange, CA
Part-time
Onsite
Entry, Mid Level
$27/hr - $30/hr
2+ years expSmarter HR Solutions, LLC is a compliance-driven research clinic specializing in liver disease trials. They are seeking a detail-oriented Regulatory Specialist to support regulatory submissions, document maintenance, compliance tracking, and study start-up activities.
ConsultingHuman ResourcesSmall and Medium BusinessesTraining
No H1B
Responsibilities
Prepare, submit, and track regulatory documents for IRB/IEC submissions, amendments, continuing reviews, and study closeouts
Maintain regulatory binders, essential documents, and version control in accordance with ICH‑GCP, FDA, and site SOPs
Support study start‑up activities including feasibility documentation, delegation logs, and training records
Communicate with sponsors, CROs, and IRBs to ensure timely responses and document updates
Assist with audit readiness and regulatory inspections by maintaining accurate, complete, and compliant documentation
Coordinate with clinical and administrative teams to ensure regulatory timelines are met
Maintain compliance with HIPAA, GCP, and institutional policies
Qualification
Required
2+ years of regulatory experience in a clinical research setting
Strong understanding of FDA, ICH-GCP, and IRB regulatory requirements
Experience preparing and submitting regulatory packets and essential documents
Excellent organizational skills and attention to detail
Strong written and verbal communication abilities
Proficiency with Microsoft Office and common clinical research platforms (CTMS, eReg, eTMF)
Ability to work independently and manage multiple deadlines
Preferred
Experience in a clinical research site environment
Familiarity with California-specific regulatory requirements
Prior experience supporting audits or inspections
Company
Smarter HR Solutions, LLC
Smarter HR Solutions' consultants and trainers have over 60 years of combined experience in Human Resources core competencies and Training and Development.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase