Clinical Documentation Specialist

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