Assistant CRA
Core
Provide support for site preparedness, logistical monitoring, and remote monitoring activities in clinical trials.
Role type
Assistant Clinical Research Associate
Builds
Clinical trial monitoring and site management processes
Domain
Pharmaceutical/Biotech clinical research
Required skills
ICH GCP knowledge, medical terminology, document management, remote monitoring, data reconciliation, system access management, supply coordination
Preferred skills
Registered Nursing certification, life science degree, vendor qualification support
Technologies
EMR/EHR, CTMS, MS Office
Responsibilities
Complete study and site management activities per task matrix, orient and train on study systems, support pre-study assessments and waivers, verify document collection and RCR status, review patient-facing materials and translations, coordinate logistics for investigator meetings, manage study/site supplies, support essential document collection, follow up on missing study data (ECGs, labs), support remote review of centralized monitoring tools, coordinate site payments and invoice reconciliation, perform trial reconciliation tasks (CRF, queries, deviations, SAEs), maintain administrative tasks like expense reports.
Seniority
Junior, 0-2 years experience