ACRA
Core
Support site preparedness, logistical monitoring, and remote monitoring activities for clinical trials in accordance with SOPs and regulatory guidelines.
Role type
Assistant Clinical Research Associate (IC)
Builds
Clinical trial data integrity and site compliance
Domain
Pharmaceutical/Biotech clinical research
Deliverable
client delivery
Required skills
ICH GCP knowledge, medical terminology understanding, document collection and verification, remote monitoring support, supply management, data reconciliation (CRF, SAEs, deviations), system access management, vendor qualification support
Preferred skills
Life science degree or Registered Nursing certification, 2+ years relevant experience, English fluency
Technologies
EMR/EHR, CTMS, MS Office
Responsibilities
Complete study and site management tasks per task matrix, orient and train on study systems, support pre-study assessments and waivers, customize Site ICF, perform remote EMR/EHR reviews, verify document collection and RCR status, review patient-facing materials and translations, support vendor qualification, manage system access for site staff, coordinate logistics for IM attendance, manage study supplies, support essential document collection, follow up on missing study data (ECGs, labs, e-diaries), support site payment processes, perform reconciliation tasks on trials (CRF, queries, deviations, SAEs), maintain administrative tasks like expense reports and timesheets
Seniority
Junior, hands-on IC