Regulatory Affairs Assistant – Independent Contractor
Position Overview
Equity Medical is seeking a detail-oriented Regulatory Affairs Assistant to provide administrative and document-management support to the Regulatory team. The primary focus of this role is maintaining accurate, complete, and audit-ready Investigational Site File (ISF) documentation within CRIO and other Company-approved systems.
The Contractor will support Regulatory Specialists by organizing, filing, tracking, and maintaining clinical trial documentation in accordance with Good Clinical Practice (GCP), study requirements, and Company procedures.
Scope of Services
Sort, index, upload, and file essential clinical trial documents within electronic and, where applicable, hard-copy Investigational Site Files (ISFs).
Process and maintain updated study documents, including protocols, protocol amendments, Investigator's Brochures (IBs), study manuals, and laboratory manuals.
File and maintain Institutional Review Board (IRB) correspondence, approvals, continuing reviews, informed consent forms, and related regulatory documentation.
Maintain accurate document versions and appropriately archive or supersede outdated documentation.
Review assigned regulatory files for completeness and identify missing, expired, or outdated documentation for follow-up.
Maintain communication with Regulatory Specialists regarding missing documentation, document versions, filing needs, and outstanding items.
Maintain regulatory documentation and applicable tracking information within CRIO and other Company-approved systems.
Ensure regulatory files are organized in accordance with study-specific requirements, applicable regulatory standards, and trial timelines.
Assist with routine document reconciliation, filing cleanup, and preparation of regulatory files for sponsor/CRO review, monitoring visits, audits, or inspections, as requested.
Perform other mutually agreed-upon administrative services reasonably related to regulatory document management and clinical research support.
Qualifications
High school diploma required; Associate's or Bachelor's degree preferred.
Prior experience in administrative filing, records management, regulatory support, or clinical research assistance preferred.
Familiarity with clinical trial documentation, including IRB materials, protocols, Investigator's Brochures, and ISF/TMF structures, is a plus.
Strong organizational skills and attention to detail with a high level of accuracy.
Ability to manage multiple documents, studies, and priorities effectively.
Strong written and verbal communication skills for coordination with the Regulatory team.
Familiarity with electronic clinical research or regulatory document-management systems, including CRIO, is preferred.
