Cancer Trials Regulatory Specialist

University of Illinois Chicago; Chicago (IL); On-site; USD 55,000 - 65,000; Full time

Job summary

The University of Illinois Chicago is seeking a Regulatory Specialist to support the Cancer Center Clinical Trials Office in Chicago. You will develop and manage regulatory documents to ensure compliance with internal, external, and federal policies for cancer clinical trials.

Responsibilities include preparing IRB submissions, maintaining regulatory binders, tracking documentation, and coordinating with investigators.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum of three years of related research experience; regulatory compliance preferred.
• Experience in a clinical research setting preferred.
• Knowledge of Federal Regulations and IRBs is required.
• Oncology research protocols preferred.
• Certification in SoCRA, ACRP, or PRIM&R preferred and required within 2 years of hire.
• Strong communication skills; clear written and verbal communication.

Responsibilities

• Collaborate with investigators to develop and implement cancer research protocols and related regulatory documents.
• Prepare study documents for IRB, sponsor, and regulatory submissions and ensure institutional approvals.
• Review IRB approved documents for accuracy before implementation of protocols.
• Maintain regulatory binders and track compliance with FDA, NCI, and sponsor guidelines.
• Prepare responses to IRB and sponsor questions.
• Monitor study progress and implement changes as needed.
• Serve as subject matter expert on regulatory issues and provide guidance to the research team.
• Educate staff on regulatory changes affecting clinical trials.
• Train and advise staff and students on procedures and techniques.
• Perform other related duties and participate in special projects.

Skills

Regulatory compliance

Clinical research

FDA regulations

IRB processes

Communication

Education

Bachelor's degree in a scientific discipline

Job description

The University of Illinois Chicago is seeking a Regulatory Specialist to support the Cancer Center Clinical Trials Office in Chicago. You will develop and manage regulatory documents to ensure compliance with internal, external, and federal policies for cancer clinical trials.

Responsibilities include preparing IRB submissions, maintaining regulatory binders, tracking documentation, and coordinating with investigators.