Clinical Study Documentation Specialist - eTMF Specialist

Role: Clinical Study Documentation Specialist supporting Caris-sponsored and collaborative research studies. Objectives include maintaining regulatory compliance, managing study documentation, coordinating IRB submissions, and ensuring study readiness. Responsibilities involve preparing study documents (protocols, ICFs), maintaining accurate files, tracking study progress in CTMS, facilitating site onboarding, and liaising with stakeholders to ensure timely approvals and compliance with GCP, HIPAA, FDA, and OHRP regulations. Requirements: Associate’s degree, 2+ years experience in IRB submissions, strong understanding of clinical research documentation and regulatory processes, proficient in Microsoft Office and clinical trial systems, with excellent organization and communication skills. Preferred qualifications include a bachelor’s in life sciences or healthcare, familiarity with electronic CTMS, and certifications such as CCRC, CCRP, or RAC. High-value specifics: focus on clinical research operations, IRB coordination, GCP/HIPAA compliance, and experience in a regulated environment. Work setup: likely office-based with potential after-hours availability for urgent regulatory issues.