Novo Nordisk - Washington, DC
posted about 2 months ago
The Clinical Research Associate (CRA) position at Novo Nordisk is pivotal in driving the understanding and delivery of quality clinical research, focusing on patient safety, rights, and well-being, as well as ensuring data reliability, scientific integrity, and regulatory compliance. The CRA will take ownership of delivering on the near-term goals of the North America Clinical Development (NACD) team, which includes the successful execution of studies within the clinical trial portfolio. This role also involves contributing to local and increasingly complex improvement and innovation projects, either as part of a global team or aligned with specific business cases and goals. In this dynamic environment, the CRA will support a future-focused approach by leveraging competencies, tools, and technology. The position requires managing relationships with external partners, such as clinical trial site staff and clinical research vendors, as well as multiple internal stakeholders across various departments, including NACD, Clinical, Medical and Regulatory (CMR), International Operations (IO), and HQ Research and Development (R&D). The CRA is expected to provide excellent customer service and build strong working relationships with investigative sites and both internal and external partners. Essential functions of the role include delivering all relevant services and tasks in support of the planning and implementation of quality-driven clinical trials, in line with established targets and strategies. The CRA will implement proactive risk identification and mitigation planning for assigned clinical trial sites, ensuring compliance with trial specifications, Standard Operating Procedures (SOPs), International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, and relevant regulatory requirements. The CRA will also verify safety reporting, ensure the accuracy and completeness of data collected at clinical trial sites, and drive recruitment and retention strategies to meet enrollment targets. Participation in audit and inspection activities, as well as collaboration with stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA), is also a key responsibility.