Research Regulatory & AR Specialist

ently maintain audit-ready regulatory documentation, coordinate IRB submissions, and support the department’s accounts receivable and sponsor payment tracking.

The right candidate is detail-oriented, calm under pressure, and thrives in a fast-paced research environment while supporting both patients and sponsors with professionalism.

Key Responsibilities

Regulatory Specialist Responsibilities
• Maintain complete and audit-ready regulatory binders (paper and electronic)
• Prepare and submit IRB documents, amendments, continuing reviews, and reportable events
• Ensure investigator and staff training documentation is current (GCP, protocol training, delegation logs)
• Track and maintain essential documents including CVs, licenses, ICFs, 1572s, DOAs, and training logs
• Support internal audits, sponsor audits, and FDA inspection readiness
• Ensure compliance with GCP, sponsor requirements, and SOPs across sites

Accounts Receivable / Research Financial Support
• Track study payments, invoicing schedules, and sponsor reimbursement timelines
• Support clinical trial invoicing, accounts receivable follow-up, and payment reconciliation
• Assist with visit-based billing verification and sponsor payment tracking
• Maintain accurate financial logs and communicate payment status with leadership
• Coordinate with internal teams to resolve missing payments or billing discrepancies

Required Qualifications
• Minimum 2 years of clinical research experience
• Strong working knowledge of GCP, regulatory requirements, and essential documents
• Proven ability to manage and maintain regulatory binders and IRB submissions
• Experience with study payment tracking, invoicing, or accounts receivable (research-related)
• Strong computer skills (Excel, Outlook, EDC systems
• Ability to travel between sites and support multi-site operations
• Excellent organization, time management, and communication skills

Preferred Qualifications
• Proficiency in Microsoft Word, Excel, and Outlook
• Experience coordinating CRA monitoring visits and study-related sponsor interactions
• Familiarity with CTMS (Clinical Trial Management Systems)
• Proficiency in Microsoft Word, Excel, and Outlook
• Associate’s degree or higher (Bachelor’s preferred)

Work Environment
• Multi-site clinical research setting (Frisco + Dallas)
• Fast-paced environment requiring flexibility and strong attention to detail

Travel required between sites for study support