Senior CRA

Extensive experience in clinical research, preferably in medical devices. Extensive on-site and remote monitoring experience. Experience developing or supporting SOPs, WIs, and process documentation. Strong understanding of GCP, ICH, FDA, and global clinical research guidelines. Proficiency with EDC, eTMF, CTMS, and standard office software. Strong communication and relationship-building skills. Ability to prioritize effectively and manage multiple responsibilities. Excellent organizational and documentation skills with attention to detail.

Lead on-site monitoring visits from qualification through close-out. Perform source data review/verification and query resolution. Evaluate site performance, compliance, enrollment trends, and data quality. Identify and escalate issues, deviations, and risks. Build collaborative site relationships and provide training. Craft and refine SOPs, WIs, and operational tools. Identify operational gaps and champion process improvements. Oversee IRB submissions and maintain TMF. Support operational activities like feasibility, regulatory submissions, and IP logistics. Contribute to study planning, risk management, and audit readiness.