Assistant CRA
Core
Support Clinical Research Associates with site preparedness, logistical monitoring, and administrative tasks for clinical trials in the pharmaceutical/biotech industry.
Role type
Junior Clinical Research Associate (Assistant CRA)
Builds
Clinical trial data integrity and site compliance for pharma/biotech clients
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
ICH GCP knowledge, medical terminology, document management, remote monitoring support, data reconciliation, system access management, supply chain coordination
Preferred skills
Registered Nursing certification, life science degree, English fluency
Technologies
CTMS, EMR/EHR, MS Office
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 Informed Consent Forms; 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; manage study/site supply chains; follow up on missing study data (ECGs, labs, e-diaries); support centralized monitoring tools; coordinate site payment processes; perform reconciliation tasks on CRFs, queries, deviations, and safety reports; maintain essential document collections; complete administrative tasks like expense reports and timesheets.
Seniority
Entry-level (0-2 years experience)