In-House Clinical Research Associate I
Core
Support the successful delivery of clinical research studies by managing site activities, ensuring compliance with GCP and regulations, and coordinating with investigative sites and cross-functional teams.
Role type
In-house Clinical Research Associate I
Builds
Clinical research studies supporting patient-focused outcomes
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Site management, GCP compliance, regulatory knowledge (FDA/EU/ICH), data quality review, remote monitoring support, documentation management, stakeholder communication
Preferred skills
Degree in medical/biological/health/pharmacy science, prior experience as Study Coordinator or Clinical Trial Assistant, familiarity with EDC/eCRF/IVRS systems
Technologies
EDC, eCRF, IVRS, Trial Master File (TMF)
Responsibilities
Support site start-up activities and document management; coordinate distribution of study materials; review site documentation for quality; conduct remote monitoring activities; maintain communication with investigative sites; review electronic case report forms and study data; assist with data queries and subject eligibility tracking; generate study reports and operational updates.
Seniority
Individual Contributor, Entry-level to Mid-level
