Clinical Research Associate - Field Management (Washington DC/Baltimore MD)

Novo Nordisk - Washington, DC

Full-time - Mid Level

Washington, DC

Merchant Wholesalers, Nondurable Goods

About the position

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.

Responsibilities

• Deliver all relevant services/tasks in support of the planning and implementation of quality-driven clinical trials, in line with established targets and strategies.
• Implement proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools.
• Execute activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials.
• Verify safety reporting and the proper handling, monitoring, and storage of trial product according to trial specifications, NN SOPs, ICH-GCP guidelines, and relevant regulatory requirements.
• Ensure accuracy, validity, and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan, and other associated trial documents.
• Comply with relevant training requirements and act as local expert in assigned protocols.
• Drive recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention targets.
• Participate in the preparation, conduct, and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA).
• Share information, collaborate, and provide relevant input and guidance to other areas within NACD, CMR, and Global partners.
• Demonstrate technical proficiency within responsible areas, staying up-to-date on new practices, systems, and technologies.

Requirements

• A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required.
• A minimum of 2 years of on-site monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research.
• Bachelor's degree required (science related discipline preferred); alternatively, a Registered Nurse with a minimum of 3 years of on-site monitoring experience is acceptable in lieu of a Bachelor's degree.
• Requires understanding of medical and scientific concepts to effectively interpret protocol requirements, support sites, and conduct monitoring activities.
• Demonstrates understanding of medical terminology and ICH-GCP principles and their application to trial planning and conduct of clinical trials.
• Demonstrates proficiency with computer skills (MS Office, MS Project, MS PowerPoint).
• Excellent communication skills (verbal, written, presentation) in English.
• Demonstrates collaborative and stakeholder management skills.