Lilly Associate-Study Monitor in Fort Dodge, Iowa
Responsible for compliance to SOPs, study protocols, GXP practices, USDA & FDA regulations as well as monitoring clinical and laboratory studies, and preparation of final study reports.
Responsible for independently monitoring all GCP and non-GCP studies at Fort Dodge, Iowa site (FD), and oversee compliance of FD R&D to SOPs, GCP/GLP/GMP practices, USDA & FDA regulations.
Monitors specific studies outside of FD (GCP,GLP, & non-GCP studies, field studies, safety studies and laboratory studies) to ensure compliance with study protocols and regulatory (USDA, EPA and FDA) requirements by contacting investigators, scheduling study site visits, auditing study records and data, and preparing Monitor Reports.
Coordinate and implement the Quality Control (QC) process of study data at FD.
Facilitate Investigational Veterinary Products (IVP) Inventory and Processes for GCP, GLP, & non-GCP studies at the Elanco Iowa Site and the submission of NCIEs to Regulatory Affairs.
Provide Technical Reviews of Protocols, Data Capture Forms and Systems, as well as support Final Study Report preparation, etc.
Coordinate training of new Study Monitors.
Collaborate with Contract Research Organizations and other outside vendors to facilitate clinical operations as directed by Project Leaders/Person(s) Responsible.
Provide support to all other activities that are directly related to maintaining compliance (USDA & FDA Inspections, internal audits, study file archiving, study binder prep, etc).
Knowledge of medical terminology
Ability to effectively communicate verbally and in writing.
Strong leadership skills.
Ability to effectively work with teams.
Strong analytical skills.
Ability to set priorities and manage multiple tasks.
Ability to travel and manage various scheduling requirements.
Effective interpersonal skills.
Working knowledge of Good Clinical Practices/Good Laboratory practices / (GCP/GLP’s).
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Bachelors or Higher
2-3 years experience with clinical drug research in an academic/industrial life science arena.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
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