Regulatory Coordinator — Cancer Trials (Hybrid: Remote)

University of Kansas Medical Center; Kansas City (KS); Hybrid; USD 80,805,000 - 109,888,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision

Paid time off

Retirement plan

Job summary

The University of Kansas Medical Center Cancer Center is seeking a Regulatory Coordinator to manage study-specific regulatory and safety reporting across multiple clinical trials. You will ensure compliance with CFR, GCP, HIPAA and organizational policies.

Responsibilities include preparing and submitting documents to the IRB, maintaining the trial master file and study credentials, and supporting monitoring visits and audits.

Qualifications

• Four years of work experience in healthcare or research setting.
• Experience with CFR, GCP, HIPAA and regulatory affairs in clinical research.
• Experience with medical terminology and Microsoft Office Suite.

Responsibilities

• Prepare and submit regulatory documents to the IRB and maintain regulatory documents.
• Maintain trial master file and study credentials; update systems with study information.
• Assist monitors during routine visits or audits and liaise with investigators and sponsors.
• Handle confidential information in compliance with policies and laws.

Skills

Initiative

Organization

Detail-Oriented

Interpersonal

Multitasking

Communication

Analytical

Problem-solving

Time management

Education

Bachelor's degree in health sciences/biology/nursing/related

Job description

The University of Kansas Medical Center Cancer Center is seeking a Regulatory Coordinator to manage study-specific regulatory and safety reporting across multiple clinical trials. You will ensure compliance with CFR, GCP, HIPAA and organizational policies.

Responsibilities include preparing and submitting documents to the IRB, maintaining the trial master file and study credentials, and supporting monitoring visits and audits.