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Senior Associate-Clinical Operations

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: Indianaagconnection
Full Time position
Listed on 2025-12-07
Job specializations:
  • Science
    Research Scientist, Clinical Research
Job Description & How to Apply Below
Location: Indianapolis
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Senior Associate-Clinical Operations  ####

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** At Elanco (NYSE: ELAN) - it all starts with animals!*
* ** As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.*
* ** At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.*
* ** At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.*
* ** Making animals' lives better makes life better - join our team today!*
* ** Your Role:
Clinical Research Associate (CRA)
** As a Clinical Research Associate, you will play a direct role in advancing Elanco's global product pipeline by monitoring clinical and laboratory studies across companion animal and farm animal programs. You'll ensure every study is conducted with integrity, accuracy, and regulatory compliance. Your work supports pivotal and pilot registration studies and connects closely with our R&D teams to help secure global approvals.

** Your Responsibilities:*
* • Proactively identify solutions and remove barriers to study progress.  
• Work effectively across Elanco R&D teams and external partners to support shared deliverables.  
• Foster a positive work environment aligned with company objectives and values.  
• Promote innovation by challenging yourself and others to deliver strong technical outcomes.  
• Demonstrate Elanco values of integrity, respect, and excellence while modeling the behavioral pillars of involve, deliver, innovate, and own.  
• Organize work to deliver high-quality, timely, and cost-effective outcomes.  
• Provide information to support accurate project and budget forecasting.

** Key Technical Responsibilities*
* • Independently oversee clinical studies in companion and farm animals, ensuring all work is conducted, recorded, and reported in compliance with protocols, SOPs, VICH GCP, and regulatory standards.  
• Prepare and ship study site documentation, regulatory materials, and correspondence.  
• Verify drug accountability during initiation and closeout visits.  
• Interact with investigator sites and third-party contract facilities.  
• Verify study data using approved Data Management tools and monitoring processes to ensure data integrity.  
• Manage query communication with study sites.  
• Support QA audits as needed.  
• Facilitate site recruitment, site training, study initiation, in-life monitoring, and close-out activities.  
• Collaborate across R&D and commercial teams based on project phase and needs.  
• Assist in preparing submissions and dossiers for global regulatory agencies.

** What You Need to Succeed (minimum qualifications):**    •
*
* Education:

** Bachelor's degree in a scientific, veterinary, or related field, or equivalent experience.  •
*
* Experience:

** Experience in clinical research, veterinary/animal health, laboratory…
Position Requirements
10+ Years work experience
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