Assistant CRA
Core
Support Clinical Research Associates with site preparedness, logistical monitoring, and administrative tasks across clinical trials.
Role type
Assistant Clinical Research Associate (IC)
Builds
Clinical trial operations and site management processes
Domain
Life Sciences / Clinical Research
Required skills
ICH GCP knowledge, medical terminology, document management, remote monitoring support, data reconciliation, system access management, supply coordination, vendor qualification support, regulatory compliance, MS Office proficiency
Preferred skills
Registered Nursing certification, life science degree, experience with EMR/EHR systems, familiarity with centralized monitoring tools
Technologies
CTMS, EMR/EHR, centralized monitoring tools, 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 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; manage study/site supply chains; support essential document collection and updates; follow up on missing study data (ECGs, labs, e-diaries); support remote review of centralized monitoring tools; coordinate site payment processes; perform reconciliation tasks on CRFs, queries, deviations, and safety reports; maintain administrative tasks like expense reports and timesheets.
Seniority
Junior, 0-2 years experience