Sponsor Dedicated CRA II/Sr CRA I/II - Home Based ITA
Core
Conducts site qualification, initiation, monitoring, and close-out visits to ensure regulatory compliance and data integrity for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and site compliance
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site management, Source Document Review, ICH-GCP compliance, Investigational Product (IP) handling, Query resolution, Audit preparation, Travel management
Preferred skills
Oncology monitoring, Phase I trials, Risk Based Monitoring
Technologies
Electronic Data Capture (EDC) systems, Tracking systems
Responsibilities
Perform site qualification, initiation, interim monitoring, and close-out visits; Verify informed consent and protect subject confidentiality; Conduct Source Document Review and verify CRF data accuracy; Manage Investigational Product inventory and administration; Review Investigator Site File (ISF) and ensure archiving compliance; Support subject recruitment and retention; Prepare for and attend investigator meetings; Provide mentorship to junior CRAs
Seniority
Senior, hands-on IC