Sr. Clinical Research Associate
Position Overview
The Sr. CRA supports project managers and/or Director, Post-Market Clinical Programs in post-market clinical research efforts.
- Supports startup and execution of post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements
- Assists project managers in protocol development as well as in the IRB/ethics approval process and audit preparation
- Reviews and prepares technical documentation including informed consents, case report forms, study tools, and study training documents
- Supports study project managers in budget and contract negotiations with clinical sites
- Performs study site qualification visits, site initiation visits, and training of site staff, monitors, and vendors
- Leads communication with study site/subsite personnel, monitors, vendors, and CROs/coordinating centers
- Partners with study project managers to track study data, enrollment trends, and other metricsPerforms other duties and responsibilities as assigned