Clinical Research Systems Specialist
Core
Enable clinical research operations by ensuring systems, study builds, and operational materials for trials are accurate, efficient, and ready for use.
Role type
Clinical Research Systems Specialist
Builds
Clinical trial systems, study configurations, and operational materials for sponsors and research sites
Domain
Clinical research operations and technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Trial Management Systems (CTMS) proficiency, clinical research workflow knowledge, protocol interpretation, quality control, user acceptance testing (UAT), database management, cross-functional collaboration
Preferred skills
Healthcare or clinical research start-up experience, ICH-GCP and Good Documentation Practice (GDP) familiarity, external vendor management
Technologies
CRIO, RealTime CTMS, Microsoft Office, Adobe
Responsibilities
Build and maintain studies within CTMS platforms; support clinical research sites in CTMS usage; partner on EHR prescreening workflows; conduct quality control reviews and UAT; interpret protocols to translate requirements into system configurations; maintain databases and trackers; provide quality control support to Budget and Contract teams; monitor quality trends and report to leadership; partner cross-functionally to support study start-up and execution; identify workflow improvement opportunities.
Seniority
Individual Contributor
