Your Role: Senior Clinical Research Associate (CRA) - Animal Health
As a Senior Clinical Research Associate (CRA) - Animal Health, you will be part of our Global Clinical Development Sciences team, responsible for leading and executing clinical monitoring for critical laboratory and field studies. In this role, you will be responsible for implementing robust monitoring plans, partnering with project teams and Contract Research Organizations (CROs) to ensure study results are of the highest quality and support global regulatory approvals for new Farm Animal and Pet Health products.
Your Responsibilities:- Lead the monitoring and execution of farm and companion animal clinical trials, providing oversight to ensure all activities remain compliant with global regulatory standards (GCP/VICH).
- Author and execute comprehensive monitoring plans, overseeing site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols.
- Serve as the primary contact and partner for investigator sites (CROs/internal sites), performing thorough data review (QC) and query resolution to ensure the highest level of data integrity.
- Collaborate with cross-functional R&D partners, including Clinical Development, Data Management, and Regulatory Affairs, to support protocol development, study planning, and final study reports.
- Serve as a primary mentor and coach for Monitoring Team colleagues, driving innovation in monitoring processes and supporting the training of new personnel.
What You Need to Succeed (minimum qualifications):- Education: Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR Master's degree in a science or health-related field with 3+ years of applicable experience.
- Experience: Proven experience monitoring single-site or multi-site clinical field safety and effectiveness studies.
- Skills: Strong knowledge of animal health concepts and global clinical trial regulations (GCP/VICH); Advanced proficiency in clinical data management systems (e.g., EDC, Veeva) and MS Office 365; Demonstrated leadership skills with the ability to communicate clinical data clearly to diverse stakeholders.
What will give you a competitive edge (preferred qualifications):- Experience with compiling clinical trial data for regulatory authority submissions (e.g., FDA/USDA dossiers).
- Experience serving as a lead monitor for specific clinical projects, coordinating the activities of other monitors.
- Demonstrated ability to mentor, coach, and train other clinical monitoring personnel.
Additional Information:- Travel: Up to 50% travel (U.S. and/or International) is required.
- Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
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
