Clinical Study Specialist
Core
Provide technical and administrative support to clinical study teams executing trials across a program, ensuring studies stay on track from site activation through close-out.
Role type
Clinical Study Specialist
Builds
Clinical trials for life-changing medicines
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Trial management systems, MS applications (Project, PowerPoint, Word, Excel), IVRS/IWRS, EDC, TMF, regulatory binders, site activation tracking, enrollment tracking, monitoring visit tracking, TMF reconciliation, close-out activities, vendor oversight
Preferred skills
Medical terminology, clinical drug development knowledge, ICH/GCP awareness, process improvement
Responsibilities
Organize and deliver analyzable reports and metrics; coordinate study team meetings, agendas, and minutes; collate data for feasibility and site selection assessments; track site activation, enrollment, and monitoring visits against projected plans; ensure timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and perform TMF reconciliations; communicate with sites and maintain contact information; contribute to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and support oversight of third-party vendors; participate in SOP revisions and departmental initiatives.
Seniority
Mid-level, hands-on IC
