Clinical Research Regulatory Coordinator 2 - Pediatric Neurology Research - Full-time

Job Description

Location:

Chicago, Illinois

Business Unit:
Rush Medical Center

Hospital:
Rush University Medical Center

Department:
Pediatric Neurology Research

Work Type:
Full Time (Total FTE between 0.9 and 1.0)

Shift: Shift 1

Work Schedule:

8 Hr (8:00:00 AM - 4:30:00 PM)

Pay Range: $29.36 - $42.61 per hour

Rush salaries are determined by many factors including, but not limited to, education, job‑related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.

The Clinical Research Regulatory Coordinator 2 (CRRC
2) prepares, submits, and maintains regulatory documents for clinical research studies across a range of study types including cooperative group, single-site, industry‑sponsored, and investigator‑initiated trials. This role manages regulatory workflows throughout the study lifecycle, including IRB submissions, institutional approvals, protocol updates, and documentation of compliance requirements. The CRRC 2 serves as the primary regulatory contact for assigned studies and collaborates with study teams to ensure version control, audit readiness, and regulatory accuracy.

Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Education: Bachelor’s degree or equivalent

Experience: 2+ years clinical experience; 2 years coordinating Human Subjects research.

• Knowledge of the Code of Federal Regulations pertaining to Human Subject Protections, including 45
  
  CFR
  46, 21
  
  CFR
  50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report and HIPAA, and RUMC policies and procedures.
• Working knowledge of electronic IRB (eIRB) and institutional research management systems.
• Ability to independently manage regulatory activities for multiple clinical trials, including industry, investigator‑initiated, cooperative group, and single‑site protocols.
• Ability to serve as the primary regulatory contact, collaborating effectively with investigators, study staff, and institutional offices.
• Ability to identify regulatory issues, apply critical thinking, and recommend workflow or compliance improvements.
• Ability to maintain audit‑ready documentation and ensure compliance with SOPs and sponsor requirements across the study lifecycle.
• Ability to manage multiple timelines and competing deadlines effectively.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook) and Adobe Acrobat.
• Clear verbal and written communication skills, including the ability to communicate complex concepts across diverse teams.
• Advanced organizational and analytical skills with high attention to detail.

Education: Master’s degree in science or health related field.

Experience: 1+ years of clinical research experience, in the academic or pharmaceutical clinical trials environment.

Certifications: Relevant certification from SOCRA or ACRP affiliated:
Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), OR Certified IRB Professional (CIP) obtained within 6 months of hire

• Ability to work independently with minimal guidance.
• Ability to maintain audit‑ready documentation and ensure compliance with SOPs and sponsor requirements.
• Informal mentorship capabilities, including willingness to assist with onboarding new staff.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

• Draft and submit IRB materials such as consent forms, new study applications, continuing reviews, and reports of unanticipated problems.
• Revise and finalize regulatory documents in response to IRB comments and submit updates within required timelines to support continued review and approval.
• Prepare and submit required documents to institutional committees (e.g.,…