Clinical Research Associate I
Core
Entry-level operational support for clinical trials, assisting senior CRAs with site monitoring visits, data accuracy checks, and document preparation to ensure protocol adherence and participant safety.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trial monitoring activities and regulatory documentation for academic research studies
Domain
Healthcare / Clinical Research
Required skills
Attention to detail, Learning agility, Planning & organizing, Problem solving, SOP adherence, Written communication
Preferred skills
EDC/CTMS systems experience, Risk-based monitoring concepts, GCP training
Technologies
CTMS, EDC
Responsibilities
Assist senior CRAs with preparation for qualification, initiation, monitoring, and close-out visits; Conduct supervised source data review (SDR) and basic source data verification (SDV); Collect, upload, and organize essential regulatory documents (TMF/ISF); Perform preliminary checks of consent documentation and review AE/SAE listings; Update study trackers and communicate site needs to senior staff.
Seniority
Entry-level, supervised IC