Clinical Research Associate - Field Management - Chicago, IL

About the position

Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for all monitoring and site management activities. Takes ownership to deliver upon near-term Clinical Development and Operations (CDO) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects for CDO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future-focused approach, leveraging competencies, tools and technology.

Responsibilities

• Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and strategies
• Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools
• Executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials
• Verifies 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
• Ensures accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan and other associated trial documents
• Complies with relevant training requirements and acts as local expert in assigned protocols
• Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention targets
• Participates in the preparation, conduct and follow-up of audit and inspection activities
• Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners
• Demonstrates 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 in order to effectively interpret protocol requirements, support sites and effectively conduct monitoring activities
• Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
• Demonstrated proficiency with computer skills (MS Office, MS Project, MS PowerPoint)
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills

Benefits

• Inclusive recruitment process
• Equality of opportunity for all job applicants
• Commitment to creating an inclusive culture that celebrates diversity