Work Location: Cook County, Illinois

Summary:
Seeking a Clinical Study Coordinator to support clinical research activities, ensuring compliance with regulatory requirements and study protocols. This role involves patient interaction, data management, and collaboration with regulatory bodies to facilitate successful clinical trials.

Responsibilities:

• Maintain and organize regulatory documentation for clinical research studies.
• Coordinate with institutional review boards for submissions, modifications, and ongoing reviews.
• Recruit, prescreen, and screen study participants according to protocol requirements.
• Conduct the informed consent process in compliance with international and good clinical practice standards.
• Document study visits and create source documents following established guidelines.
• Collect, process, and ship biological samples as specified in study protocols and laboratory manuals.
• Enter and manage clinical data in electronic data capture systems, addressing queries promptly.
• Perform study-related assessments, monitor investigational products, and ensure accurate reporting of adverse events.

Qualifications:

• Bachelor's degree required.
• Minimum of 1 year experience in a regulated industry supporting sponsored drug trials.
• Certification in Good Clinical Practice (GCP) and International Air Transport Association (IATA) required.

Published Category: Clinical Operations & Development