Records Specialist
Core
Manage global records and file room support for clinical study teams, ensuring compliance with SOPs and WPDs for Trial Master Files (TMF/eTMF) and Case Report Forms (CRF).
Role type
Records Specialist (Clinical Research Operations)
Builds
Trial Master Files (TMF/eTMF), Case Report Forms (CRF), and global records management systems
Domain
Clinical research / Life sciences / Document management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Document management software proficiency, eTMF expertise, filing process knowledge, data analysis, training delivery, independent project execution
Preferred skills
Associate's degree, second language proficiency
Technologies
Document management software, eTMF systems
Responsibilities
Process and index incoming study documents (paper and electronic), assist study teams with TMF/eTMF and CRF filing, act as subject matter expert on filing processes, resolve filing and quality review issues, maintain records classification and retention systems, conduct training for staff and clients
Seniority
Mid-level, hands-on IC