In-house CRA I/ In-house CRA II
Core
Provides centralized, non-site-facing operational and administrative support to Clinical Research Associates (CRAs) and clinical project teams across the study lifecycle, including document management, data reconciliation, and metrics reporting.
Role type
In-house Clinical Research Associate (IHCRA)
Builds
Study documentation, operational metrics, and audit-ready files for clinical trials
Domain
Clinical Research / Pharmaceutical / Biotechnology
Required skills
Document review and filing, data reconciliation, system administration (CTMS, eTMF), report generation, supply tracking, risk escalation, ICH-GCP compliance
Preferred skills
Experience with Veeva Clinical applications, multi-country study support
Technologies
CTMS, eTMF, Microsoft Office (Outlook, Word, Excel, PowerPoint), Veeva Clinical
Responsibilities
Prepare and maintain Investigator Site Files; review eTMF for missing/expiring documents; reconcile data between Delegation of Authority Log, CTMS, and eTMF; set up and maintain site-level data and milestones in CTMS; run reports on site metrics (enrollment, approval status); support sample tracking and vendor reconciliations; complete administrative actions from CRA site contacts; support audit and inspection readiness.
Seniority
Entry to Mid-level, hands-on IC
