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.
Role type
In-house Clinical Research Associate (IHCRA)
Builds
Investigator Site Files, study documentation, operational metrics, and audit readiness support
Domain
Clinical Research / Oncology / Rare Disease
Required skills
Document review and reconciliation, Clinical Trial Management Systems (CTMS) proficiency, Electronic Trial Master File (eTMF) management, Data cleaning and metrics reporting, Vendor coordination, ICH-GCP compliance
Preferred skills
Veeva Clinical applications experience, Multi-country study support
Technologies
CTMS, eTMF, Veeva Clinical, Microsoft Office Suite
Responsibilities
Maintain Investigator Site Files and route site communications to CRAs; Review eTMF for missing/expiring documents and provide follow-up lists; Perform reconciliations between Delegation of Authority Log, CTMS, and eTMF; Set up and maintain site-level data and milestones in CTMS; Run reports to provide site metrics (enrollment, approval status) to CRAs; Support sample tracking and vendor reconciliations; Complete administrative actions arising from CRA site contacts; Support audit and inspection readiness.
Seniority
Entry to Mid-level, hands-on IC
