Senior Clinical Research Associate (CRA) – Animal Health
Elanco
Summary
As a Senior Clinical Research Associate (CRA) – Animal Health, you will be a key member of our Global Clinical Development Sciences team, dedicated to advancing Elanco’s portfolio of Farm Animal and Pet Health products. In this role, you will be responsible for guiding and executing crucial clinical monitoring for laboratory and field studies, partnering with project teams and CROs to ensure our study results meet global regulatory standards and drive successful product registrations.
Job description
Your Responsibilities
- Oversee the monitoring and execution of farm and companion animal clinical trials, ensuring all activities comply with global regulatory standards (GCP/VICH) and internal policies.
- Author and execute comprehensive monitoring plans; conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study requirements.
- Perform thorough data review (QC) and query resolution to ensure the highest level of data integrity and quality across all assigned studies and projects.
- Serve as the primary contact for investigator sites and third-party organizations (CROs), overseeing study site documentation, investigational material shipments, and drug accountability.
- Collaborate with cross-functional partners, including Regulatory Affairs and Data Management, to support protocol development, study planning, and the development of final study reports and submission files.
What You Need to Succeed (minimum qualifications)
- Education & Experience: A Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR a Master’s degree in a science or health-related field with 3+ years of applicable experience.
- Clinical Trial Experience: Proven experience monitoring single-site or multi-site clinical field studies for safety and effectiveness.
- Key Skills: Demonstrated interpersonal skills with the ability to work within and across interdisciplinary teams, combined with a strong knowledge of animal health concepts and global clinical trial regulations.
What will give you a valuable edge (preferred qualifications)
- Direct experience with regulatory authority submissions and a deep understanding of the data requirements for successful filings.
- Experience acting as a lead monitor or mentor for other Clinical Research Associates on clinical projects.
- Advanced proficiency in clinical trial management systems, such as Veeva Vault, and other collaborative tools.
- Specialized experience in either Farm Animal or Pet Health clinical studies.
- Proven ability to anticipate issues and proactively ensure innovative solutions in a fast-paced, matrixed environment.
Additional Information
- Travel: Up to ~50%
- Location: US - Teleworker
Requirements
- Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR a Master’s degree in a science or health-related field with 3+ years of applicable experience.
- Proven experience monitoring single-site or multi-site clinical field studies for safety and effectiveness.
- Demonstrated interpersonal skills with the ability to work within and across interdisciplinary teams.
- Strong knowledge of animal health concepts and global clinical trial regulations.
Benefits
- Relocation packages
- Two weeklong shutdowns
- Parental leave
- Employee resource groups
- Annual bonus
- Flexible work arrangements
- 401(k) matching
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.