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Title: Sr. Clinical Research Associate (CRA) - Site Monitor (Level II - Senior CRA)
Reports To: Senior Director, Clinical Operations
Travel: Up to 60% travel to investigative sites
Full-time role
Who We Are: NX Development Corp. is a dynamic and innovative organization committed to enhancing patient outcomes and advancing research and development in the use of Gleolan®, a real-time imaging agent that aids surgeons in tumor visualization during surgery. Our team prioritizes excellence and collaboration, and we are seeking a Sr. Clinical Research Associate to contribute to our mission.
Position Overview: The Sr. Clinical Research Associate supports Clinical Operations projects, site management, and monitoring activities. This role requires a cross-functional skill set with strong attention to detail for timelines and site management. The Sr. CRA will perform quality and compliant site monitoring and management in accordance with industry best practices (ICH GCP) and procedures set forth by NXDC across all stages of clinical study development, execution, monitoring, and closeout. The Sr. CRA will perform both on-site and remote monitoring to ensure subject safety, the highest level of data integrity, and contribute to proactive risk management and inspection readiness.
This role will collaborate closely with key cross-functional internal stakeholders, including Clinical Operations, Medical Monitoring, Data Management, external CRO and vendor partners, Clinical Compliance, and Quality Assurance, to guarantee quality study oversight from study start-up through close-out