Clinical Research Associate II
Core
On-site monitoring of clinical trials to ensure data integrity, subject protection, and regulatory compliance across study sites.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Source data verification, informed consent verification, regulatory compliance (ICH GCP), site monitoring, data quality review, travel management
Preferred skills
Lead CRA responsibilities, investigator recruitment assistance, eCRF review
Technologies
eTMF, client data management systems
Responsibilities
Conduct pre-study, initiation, routine, and close-out site monitoring visits; verify informed consent and protocol adherence; perform source document review and data quality checks; ensure Investigational Product inventory accuracy; prepare trip reports and manage travel expenses; act as Lead CRA when assigned.