Senior CRA level I
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trials across 100+ countries for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis (RCA), Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Travel management
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, Process improvement initiatives
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data accuracy checks and product inventory; Initiate clinical trial sites and ensure compliance with protocol and regulations; Prepare trial status reports and manage study system updates; Respond to regulatory audits and inspections; Manage administrative tasks including expense reports and timesheets.
Seniority
Senior, hands-on IC