Clinical Research Associate I
Core
Entry-level operational support for clinical trials by assisting senior CRAs with routine monitoring, data accuracy checks, document preparation, and visit scheduling to ensure protocol adherence and data integrity.
Role type
Junior Clinical Research Associate (CRA I)
Builds
Clinical trial monitoring visits and regulatory documentation for psychiatric research studies
Domain
Healthcare / Clinical Research / Psychiatry
Required skills
Source data verification (SDV), chart review, document management (TMF/ISF), query tracking, GCP compliance, data accuracy checks, study tracker maintenance, eligibility verification
Preferred skills
EDC/CTMS systems experience, risk-based monitoring concepts, 1 year clinical research support experience, GCP training, ACRP/SOCRA certification
Technologies
CTMS, EDC, IVRS/IWRS, eCOA
Responsibilities
Assist senior CRAs with qualification, initiation, monitoring, and close-out visits; conduct supervised source data review and verification; collect and organize essential regulatory documents; review consent forms and AE/SAE listings for completeness; update study trackers and communication logs; prepare training materials and feasibility documentation.
Seniority
Entry-level, supervised IC