Senior Clinical Research Associate - EAST COAST

Role: Senior Clinical Research Associate (Sr. CRA) supporting Phase 1-3 clinical trials, overseeing site management, monitoring, and compliance. Responsibilities: conduct site qualification, initiation, monitoring, and close-out visits; develop and maintain strong investigator relationships; review source data, regulatory documents, and investigational product handling; ensure adherence to GCP, ICH, and local regulations; manage documentation in CTMS/eTMF; train and support site staff; escalate issues and oversee CRO activities including monitoring assessments. Qualifications: BS in biological sciences or related field; minimum 5 years CRA experience; strong understanding of clinical trial processes, GCP, ICH, and regulatory requirements; excellent communication, negotiation, and problem-solving skills. Preferred: experience in risk-based monitoring and startup/closeout activities; monitoring in early-phase trials. High-Value: extensive site management experience in Phase 1-3, possibly with biologics or small molecules; significant travel up to 75%; emphasis on site relationships, regulatory compliance, and monitoring oversight.