Freelance Senior Clinical Research Associate
Core
Senior Clinical Research Associate providing unmasked monitoring support for ophthalmology clinical trials, ensuring site compliance, data integrity, and patient safety.
Role type
Senior Clinical Research Associate (Unmasked Monitor)
Builds
Clinical trial data and regulatory compliance for biotechnology and pharmaceutical sponsors
Domain
Clinical Research / Ophthalmology
Deliverable
client delivery
Required skills
Independent on-site monitoring, protocol compliance verification, Investigational Product accountability, CRF review, GCP/ICH guidelines knowledge, audit/inspection preparation, site file management, travel management
Preferred skills
Ophthalmology experience (retina indications), mentoring CRAs, therapeutic area training development, project tracking assistance
Technologies
eTMF, CTMS, electronic CRF systems
Responsibilities
Monitor clinical trials on-site and remotely per GCP/ICH guidelines; Verify informed consent and protocol adherence; Review CRFs and source documentation for accuracy; Manage Investigational Product accountability; Report monitoring findings and corrective actions; Deliver site documents to eTMF; Maintain Investigator's Site File; Update CTMS; Participate in audit/inspection activities; Order and reconcile clinical supplies; Assist in project tracking and monitoring plans; Mentor CRAs and develop training materials
Seniority
Senior, hands-on IC with mentorship capabilities
