Clinical Research Associate - Field Management (Irvine/Palm Springs, CA)

$123,000 - $123,000/Yr

Novo Nordisk - Irvine, CA

Full-time - Mid Level

Irvine, CA

Merchant Wholesalers, Nondurable Goods

About the position

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a dynamic and diverse group dedicated to improving patient outcomes through innovative clinical research. This position plays a crucial role in ensuring the quality and integrity of clinical trials, focusing on patient safety, data reliability, and regulatory compliance. The successful candidate will take ownership of North America Clinical Development (NACD) goals, contributing to the successful delivery of studies within the clinical trial portfolio. This role involves engaging in improvement and innovation projects, adapting to a continually changing environment, and leveraging advanced tools and technology to enhance clinical research processes. In this position, you will be responsible for managing relationships with external partners, including clinical trial site staff and research vendors, as well as internal stakeholders across various departments. You will provide excellent customer service and build strong working relationships to facilitate the planning and implementation of clinical trials. Your essential functions will include delivering quality-driven clinical trial services, implementing proactive risk management strategies, ensuring compliance with safety reporting, and verifying the accuracy of data collected at trial sites. You will also participate in audit and inspection activities, collaborating with stakeholders to develop corrective action plans as needed. This role requires a proactive approach to recruitment and retention strategies to meet enrollment targets, as well as a commitment to staying updated on new practices and technologies in the field. The position demands a strong understanding of medical and scientific concepts, excellent communication skills, and the ability to balance multiple priorities effectively. As part of a job family, the title and level will be determined based on experience and business needs, with competitive compensation and benefits offered.

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.
• 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 and relevant 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.
• Develop therapeutic area knowledge sufficient to support role and responsibilities.
• Drive recruitment and retention strategies to support clinical trial sites to meet enrollment targets.
• Participate in the preparation, conduct, and follow-up of 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.

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.
• Requires understanding of medical and scientific concepts to effectively interpret protocol requirements and support sites.
• Demonstrates understanding of medical terminology and ICH-GCP principles and their application to trial planning and conduct.
• Demonstrates proficiency with computer skills (MS Office, MS Project, MS PowerPoint).
• Excellent communication skills (verbal, written, presentation) in English are required.
• Demonstrates collaborative and stakeholder management skills.

Nice-to-haves

• Experience with Risk Based Quality Management (RBQM) principles and tools.
• Knowledge of emerging trends and advances within the clinical research area.

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.
• Sick time policy
• Flexible vacation policy
• Parental leave policy
• Company bonus based on individual and company performance.
• Long-term incentive compensation and/or company vehicles depending on position level.