Sr CRA
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 (IC)
Builds
Clinical study data and patient safety records
Domain
Biopharmaceuticals / Clinical Development
Required skills
ICH-GCP knowledge, source document review, informed consent verification, investigational product management, audit readiness, site performance evaluation, query resolution, travel management
Preferred skills
Mentorship of junior CRAs, real-world late phase study design knowledge, chart abstraction, country-level informed consent form development
Technologies
Electronic data capture systems, tracking systems
Responsibilities
Perform site qualification, initiation, interim monitoring, and close-out visits ensuring regulatory compliance. Verify informed consent processes and protect subject confidentiality. Conduct source document reviews and verify clinical data accuracy in CRFs. Manage investigational product inventory, storage, and administration. Review Investigator Site Files for accuracy and completeness. Document activities via trip reports and communication logs. Support subject recruitment and retention strategies. Manage site-level activities and communication to meet project timelines. Provide guidance on audit readiness and support preparation for audits. Mentor junior CRA staff as assigned.
