CRA (Level I)
Core
Clinical Research Associate I performing on-site and remote monitoring of investigator sites to ensure clinical trials comply with protocols and regulations.
Role type
Junior Clinical Research Associate (CRA I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/medical device studies
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Source data verification (SDV), risk-based monitoring, ICH-GCP knowledge, site compliance assessment, root cause analysis, investigational product accountability, clinical trial systems proficiency
Preferred skills
Life Sciences/Pharmacy/Medicine degree, 2 years clinical monitoring experience, medical terminology knowledge, English fluency
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits, perform source data review and verification, assess site compliance with protocols and GCP, document monitoring observations, manage investigational product inventory, facilitate communication between sites and sponsors, support audit and inspection responses
Seniority
Junior, hands-on IC