Study Management Coordinator - Clinical Development

Elanco•Fort Dodge, IA

18d•Onsite

About The Position

The Study Management Coordinator provides critical administrative assistance for regulated, including GLP, and non-regulated clinical studies. The role focuses on meticulous data and record management, quality control, and maintenance of electronic data capture systems and audit readiness. As part of Clinical Development Sciences, the coordinator helps uphold the quality standards needed to protect the integrity and success of clinical studies. The position supports study protocols and data capture, manages study records and vendors, helps maintain regulatory compliance and inspection readiness, and provides guidance to study personnel. The role is based on-site in Fort Dodge, Iowa, and involves travel of up to 10%.

Requirements

Bachelor's degree in a scientific discipline, such as Biology, Chemistry, Animal Science, or Veterinary Medicine.
2–5 years of experience in a GLP-regulated environment, preferably in a Quality Assurance or Study Management role.
Thorough understanding of FDA 21 CFR Part 58 and/or OECD GLP Principles.
Familiarity with other relevant regulations, such as the Animal Welfare Act and specific industry guidelines.

Nice To Haves

Clinical study management or coordination experience in the Animal Health industry.
Strong attention to detail and ability to identify non-compliance issues.
Strong organizational skills and ability to manage multiple tasks and priorities.
Excellent written and verbal communication skills for preparing reports, SOPs, and training materials.
Knowledge and experience organizing clinical functional groups, including regulatory, clinical laboratory, clinical execution, veterinary services, and animal care personnel, and ability to work effectively in a team.
Effective communication skills.
Master's degree in a relevant scientific discipline.

Responsibilities

Assist with preparing and reviewing study protocols, data capture forms, amendments, and deviations.
Guide study personnel on regulatory requirements, including GLP, and uphold standards for data integrity and consistency.
Facilitate Electronic Data Capture (EDC) systems and oversee indexing, quality control, and review of study files for completeness and accuracy.
Manage external vendors, particularly vendors providing data for GLP studies.
Assist with preparing Animal Care and Use Protocols (ACUPs).
Maintain an overview of records for clinical studies, including equipment calibration, maintenance, and room monitoring.
Assist in maintaining GLP compliance for laboratory equipment and support facility inspections and quality assurance audits.
Provide guidance to new and existing study personnel.
Stay current with evolving GLP regulations and industry best practices.
Facilitate resolution of GLP-related issues identified during study conduct.