Clinical Study Documentation Specialist

Job Summary

Providing essential support for clinical studies, the full-time Clinical Study Documentation Specialist will manage the preparation and submission of study documents, maintain clinical study files, and coordinate communications with research sites and regulatory bodies in a remote setting.

Key responsibilities

• Prepare and submit study documents to Institutional Review Boards (IRBs) for clinical trials
• Maintain accurate clinical study documentation, ensuring compliance and readiness for audits
• Coordinate regular reviews of study binders and systems to ensure document integrity and protocol alignment

Required qualifications

• Associates degree
• 2 years of experience with document preparation and submission to IRBs
• Strong understanding of clinical research documentation and regulatory processes
• Proficient in Microsoft Office Suite and internet-based regulatory systems
• Ability to manage multiple studies with minimal supervision