Senior Clinical Research Associate
Core
Monitoring clinical trials at study sites to ensure subject safety, data integrity, and regulatory compliance for pharmaceutical and biotechnology sponsors.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial execution and data quality for global pharma/biotech sponsors
Domain
Clinical research / Life sciences
Deliverable
physical/clinical work
Required skills
On-site and remote monitoring, GCP and ICH guidelines knowledge, CRF and source documentation review, Investigational Product management, Regulatory compliance verification, Deficiency reporting and corrective action planning
Preferred skills
Life science or nursing background, Medical terminology understanding
Technologies
eTMF, electronic CRF systems
Responsibilities
Monitor clinical trials on-site and remotely per SOPs; Verify informed consent and protocol adherence; Review CRFs and source documentation for accuracy; Manage Investigational Product accountability; Report monitoring findings and action items; Deliver site documents to TMF; Maintain Investigator's Site File per GCP/ICH guidelines
Seniority
Senior, hands-on IC
