Sr. CRA (Level II)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for clinical trials in the pharmaceutical/biotech industry.
Role type
Senior IC Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for sponsors and CROs
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation and close-out, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Mentoring junior staff
Preferred skills
None explicitly stated
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to ensure protocol and regulatory compliance; Conduct on-site and remote monitoring including data review and inventory checks; Initiate and close out clinical trial sites; Manage essential documents and ensure audit readiness; Mentor and train junior clinical team members; Provide trend analysis and status reports to management; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC