Clinical Research Associate I
Core
Entry-level operational support for clinical trials, assisting senior CRAs with site monitoring, data verification, and document management to ensure protocol adherence and participant safety.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trial monitoring activities and data integrity for psychiatric research studies
Domain
Healthcare / Clinical Research / Psychiatry
Deliverable
client delivery
Required skills
Source data verification (SDV), chart review, document collection and organization, query tracking, study tracker maintenance, regulatory document management (TMF/ISF), basic GCP knowledge
Preferred skills
EDC/CTMS system experience, risk-based monitoring concepts, 1+ year clinical research support experience, GCP training
Technologies
CTMS, EDC
Responsibilities
Assist senior CRAs with preparation for qualification, initiation, monitoring, and close-out visits; Conduct supervised source data review and basic source data verification; Collect, upload, and organize essential regulatory documents; Perform preliminary checks of consent documentation and AE/SAE listings; Update study trackers and communicate site status updates
Seniority
Entry-level, supervised IC