Clinical Research Associate
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Orlando • Florida • United States
Visit company websiteExplore more
Tech Stack
About the role
- Drives the understanding and delivery of quality clinical research for all monitoring and site management activities
- Takes ownership to deliver upon near-term Clinical Development Organization (CDO) goals
- Contributes to local or increasingly complex improvement/innovation projects for CDO and/or as part of a global team
- Implements proactive risk identification and mitigation planning for assigned clinical trial sites
- Verifies safety reporting and the proper handling, monitoring and storage of trial product according to trial specifications
- Ensure accuracy, validity and completeness of data collected at clinical trial sites
- Complies with relevant training requirements
- Develops therapeutic area knowledge sufficient to support role and responsibilities
- Drives recruitment and retention strategies to support clinical trial sites
- 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 CDO, CMR, and Global partners
- Demonstrates technical proficiency within responsible areas
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
- Proficient in Spanish is highly preferred
- 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
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial experienceon-site monitoring experiencemedical terminologyICH-GCP principlesdata accuracyrisk identificationmitigation planningtherapeutic area knowledgesafety reporting
Soft Skills
communication skillscollaborative skillsstakeholder managementproblem-solvinginnovationleadershiporganizational skills
Certifications
Bachelor’s degreeRegistered Nurse