Your Role: Senior Clinical Research Associate (CRA) - Animal Health
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.
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
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose!
Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
