Senior Clinical Research Associate - Cardiovascular (In-House)

Role: Clinical Operations Lead supporting complex cardiovascular clinical trials at Edgewise, focusing on site start-up, monitoring oversight, vendor management, and study process adherence. Responsibilities: oversee site initiation activities, negotiate budgets/contracts, review study documents, monitor site and vendor performance, ensure data quality, manage study progress, and support regulatory and TMF activities. Collaborate cross-functionally with teams like Regulatory, Data Management, and Medical Monitoring to ensure seamless trial execution. Requirements: ≥4 years of clinical operations experience, including ≥4 years of independent on-site monitoring, with preference for ≥3 years in cardiac studies within a pharma/biotech environment; BS or BA in Life Sciences; proficiency in MS Office and knowledge of GCP, FDA, ICH guidelines. Preferred: experience with complex, high-risk trials, vendor oversight, and regulatory inspections. HighValue: cardiovascular focus, site start-up & monitoring, vendor management, GCP compliance, hybrid work, 20-50% travel, Colorado-based preferred.