Assistant CRA
Core
Support Clinical Research Associates with site preparedness, logistical monitoring, and administrative tasks to ensure study compliance and data integrity.
Role type
Junior Clinical Research Associate (Assistant CRA)
Builds
Clinical trials for pharmaceutical and biotech companies
Domain
Life Sciences / Clinical Research
Required skills
ICH GCP knowledge, medical terminology, document management, remote monitoring support, data reconciliation, regulatory compliance, vendor coordination, system access management, supply chain coordination, critical thinking
Preferred skills
Registered Nursing certification, life science degree, experience with EMR/EHR systems, familiarity with centralized monitoring tools
Technologies
MS Office, CTMS, electronic study data systems, centralized monitoring tools
Responsibilities
Complete study and site management activities per task matrix; orient and train on study-specific systems; support pre-study assessments and waivers; customize Site ICFs; perform remote review of EMR/EHR checklists; verify document collection and RCR submission status; review patient-facing materials and translations; support vendor qualification processes; coordinate logistics for investigator meetings; maintain vendor trackers; manage study/site supply; support essential document collection and updates; follow up on missing study data (ECGs, labs, e-diaries); support ongoing remote review of centralized monitoring tools; support site payment processes and invoice reconciliation; perform reconciliation tasks on CRFs, queries, deviations, and safety reports.
Seniority
Junior, 0-2 years experience