Experienced CRA II/Sr CRA - US Northeast Region - Multiple Therapeutic Areas Available
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clients.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trials across multiple therapeutic areas
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP knowledge, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Travel management
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems, Process improvement
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Initiate and close out clinical trial sites; Conduct on-site file reviews and physical inventory checks; Track trial status and provide progress reports to management; Respond to regulatory audits and inspections; Manage investigator payments and site relationships.
Seniority
Senior, hands-on IC