Clinical Research Regulatory Specialist II

Rush University Medical Center; Chicago (IL); On-site; USD 61,000 - 89,000; Full time

Benefits offered by this job

Exceptional rewards and benefits

Job summary

Rush University Medical Center is seeking a Clinical Research Regulatory Coordinator 2 to manage and maintain regulatory documents for clinical research studies. This role is vital in ensuring compliance with IRB submissions, protocol updates, and managing regulatory workflows across various study types.

The ideal candidate will have a Bachelor’s degree, hands-on experience in human subjects research, and a thorough understanding of federal regulations. This full-time position supports a collaborative and compliance-driven environment.

Qualifications

• 2+ years clinical experience and 2 years coordinating Human Subjects research.
• Ability to serve as the primary regulatory contact and collaborate effectively.

Responsibilities

• Draft and submit IRB materials and regulatory documents.
• Manage regulatory activities for multiple clinical research studies.
• Implement protocol amendments and maintain version control.

Skills

Knowledge of Code of Federal Regulations

Working knowledge of electronic IRB systems

Ability to manage multiple clinical trials

Clear verbal and written communication

Proficient in Microsoft Office Suite

Advanced organizational and analytical skills

Education

Bachelor’s degree or equivalent

Master’s degree in science or health related field

Job description

Rush University Medical Center is seeking a Clinical Research Regulatory Coordinator 2 to manage and maintain regulatory documents for clinical research studies. This role is vital in ensuring compliance with IRB submissions, protocol updates, and managing regulatory workflows across various study types.

The ideal candidate will have a Bachelor’s degree, hands-on experience in human subjects research, and a thorough understanding of federal regulations. This full-time position supports a collaborative and compliance-driven environment.