Sr. Clinical Research Associate

NX Development Corp.; United States; Ibrido; USD 75.000 - 95.000; Tempo pieno

Descrizione del lavoro

An innovative healthcare organization is seeking a Senior Clinical Research Associate (CRA) to monitor clinical trial sites and ensure compliance with industry standards. The role requires up to 60% travel and involves collaboration with various internal teams and external partners. The ideal candidate will have strong attention to detail and expertise in site management while supporting clinical study development from start to close-out. Join a team committed to advancing patient outcomes through innovative research.

Competenze

• Experience with clinical research monitoring and site management.
• Strong understanding of clinical trial phases and regulations.
• Proven ability to manage timelines and cross-functional teams.

Mansioni

• Support Clinical Operations projects and site management activities.
• Perform quality and compliant site monitoring in alignment with ICH GCP.
• Collaborate with internal and external stakeholders throughout the study lifecycle.

Conoscenze

Attention to detail

Site management

Cross-functional collaboration

Compliance with ICH GCP

Data integrity

Descrizione del lavoro

Overview

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