Clinical Research Coordinator I - Data-Driven Trials & Compliance

University of Minnesota; Minneapolis (MN); On-site; USD 41,000 - 55,000; Full time

Job summary

The Clinical Research Coordinator I at University of Minnesota supports data collection, study documentation, and protocol procedures under GCP guidelines. You will work with the PI and study team to ensure accurate implementation and compliance, including IRB, FDA, CFR, and ICH standards.

Key duties include data abstraction, study document maintenance, and coordination of visits with sponsors and monitors to ensure timely, audit-ready records across campus.

Qualifications

• BA/BS degree or combination of education and health-care related work experience to equal at least four years.
• Excellent attention to detail and organizational skills.
• Ability to work independently, as part of a team, and with changing priorities.
• Computer proficiency in a PC environment including Microsoft Office products.
• Ability to sit for extended periods of time.

Responsibilities

• Serves as primary contact for the collection and completion of required study documentation.
• Develops and maintains study documentation to ensure audit-proof compliance.
• Abstracts data from medical records to ensure accurate source documentation.
• Manages electronic data capture systems, including CRF development, queries, and data lock deadlines.
• Collaborates with PI to interpret protocols and create source documents.

Skills

Attention to detail

Organizational skills

Independent work

Microsoft Office

Education

BA/BS degree or equivalent

Tools

Epic/Oncore

Job description

The Clinical Research Coordinator I at University of Minnesota supports data collection, study documentation, and protocol procedures under GCP guidelines. You will work with the PI and study team to ensure accurate implementation and compliance, including IRB, FDA, CFR, and ICH standards.

Key duties include data abstraction, study document maintenance, and coordination of visits with sponsors and monitors to ensure timely, audit-ready records across campus.