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) - Field Management role at Novo Nordisk focuses on ensuring the quality and compliance of clinical research activities. The position involves monitoring clinical trials, managing relationships with external partners, and contributing to improvement projects within the North America Clinical Development (NACD) team. The CRA will play a crucial role in patient safety, data reliability, and regulatory compliance while driving recruitment and retention strategies for clinical trial sites.

Responsibilities

• Deliver all relevant services/tasks in support of the planning and implementation of quality-driven clinical trials.
• Implement proactive risk identification and mitigation planning for assigned clinical trial sites using Risk Based Quality Management (RBQM) principles.
• Verify safety reporting and ensure proper handling, monitoring, and storage of trial products according to trial specifications and regulatory requirements.
• Ensure accuracy, validity, and completeness of data collected at clinical trial sites in accordance with the protocol and Monitoring Plan.
• Comply with relevant training requirements and act as a local expert in assigned protocols.
• Drive recruitment and retention strategies to meet country enrollment and retention targets for clinical trial sites.
• Participate in audit and inspection activities, collaborating with stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA).
• Share information and provide relevant input and guidance to other areas within NACD, CMR, and Global partners.
• Demonstrate technical proficiency and stay updated 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, although this may be waived with relevant Novo Nordisk experience in GCP-related clinical research.
• Bachelor's degree required (science-related discipline preferred) or a Registered Nurse with a minimum of 3 years of on-site monitoring experience in lieu of a Bachelor's degree.
• Understanding of medical and scientific concepts to effectively interpret protocol requirements and support sites.
• Demonstrated understanding of medical terminology and ICH-GCP principles.
• Proficiency with computer skills (MS Office, MS Project, MS PowerPoint).
• Excellent communication skills (verbal, written, presentation) in English.
• Demonstrated collaborative and stakeholder management skills.