Consultant- Clinical Operations
Elanco
August 25, 2026
Remote friendly (Fort Dodge, IA)
United States
Operations
Senior Clinical Research Associate (CRA) – Animal Health
Responsibilities:
- Lead monitoring and execution of farm and companion animal clinical trials, ensuring compliance with GCP/VICH.
- Author and execute monitoring plans (site qualification, initiation, routine monitoring, close-out) per study protocols.
- Primary contact for investigator sites (CROs/internal sites); perform QC data review and query resolution for data integrity.
- Collaborate cross-functionally (Clinical Development, Data Management, Regulatory Affairs) on protocol development, study planning, and final study reports.
- Mentor/coach Monitoring Team colleagues; support innovation in monitoring processes and training of new personnel.
Minimum Qualifications:
- Bachelor’s in science/health-related field + 5+ years applicable experience, or Master’s + 3+ years.
- Proven experience monitoring single-site or multi-site clinical field safety and effectiveness studies.
- Strong knowledge of animal health concepts and global clinical trial regulations (GCP/VICH).
- Advanced proficiency with clinical data management systems (e.g., EDC, Veeva) and MS Office 365.
- Demonstrated leadership and ability to communicate clinical data to diverse stakeholders.
Preferred Qualifications:
- Experience compiling clinical data for regulatory submissions (e.g., FDA/USDA dossiers).
- Experience as lead monitor coordinating other monitors.
- Ability to mentor/coach/train clinical monitoring personnel.
Additional Information:
- Travel up to 50% (U.S. and/or International); Hybrid work; Indianapolis, IN (Global Elanco Headquarters).
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns (mid-summer/year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401K matching.
Responsibilities:
- Lead monitoring and execution of farm and companion animal clinical trials, ensuring compliance with GCP/VICH.
- Author and execute monitoring plans (site qualification, initiation, routine monitoring, close-out) per study protocols.
- Primary contact for investigator sites (CROs/internal sites); perform QC data review and query resolution for data integrity.
- Collaborate cross-functionally (Clinical Development, Data Management, Regulatory Affairs) on protocol development, study planning, and final study reports.
- Mentor/coach Monitoring Team colleagues; support innovation in monitoring processes and training of new personnel.
Minimum Qualifications:
- Bachelor’s in science/health-related field + 5+ years applicable experience, or Master’s + 3+ years.
- Proven experience monitoring single-site or multi-site clinical field safety and effectiveness studies.
- Strong knowledge of animal health concepts and global clinical trial regulations (GCP/VICH).
- Advanced proficiency with clinical data management systems (e.g., EDC, Veeva) and MS Office 365.
- Demonstrated leadership and ability to communicate clinical data to diverse stakeholders.
Preferred Qualifications:
- Experience compiling clinical data for regulatory submissions (e.g., FDA/USDA dossiers).
- Experience as lead monitor coordinating other monitors.
- Ability to mentor/coach/train clinical monitoring personnel.
Additional Information:
- Travel up to 50% (U.S. and/or International); Hybrid work; Indianapolis, IN (Global Elanco Headquarters).
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns (mid-summer/year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401K matching.