Clinical Research Regulatory Coordinator I - Pediatric Neurology Research - Full-time
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)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ([click to reveal website link]).
Pay Range: $23.12 - $32.66 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.
Summary:
Job Summary:
The Clinical Research Regulatory Coordinator 1 (CRRC 1) assists in the preparation, submission, and maintenance of regulatory documentation for clinical research studies under supervision. This role supports IRB submissions, tracks institutional approvals, and helps maintain audit-ready regulatory files. The CRRC 1 contributes to communication with study teams and regulatory stakeholders to support timely study start-up and continued compliance
Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Other information:
Required Job Qualifications:
Education: Bachelor's degree or equivalent
Experience: 1+ years of clinical research or healthcare-related experience
Knowledge, Skills, and Abilities
Knowledge of the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report and HIPAA, and RUMC policies and procedures.
Familiarity with electronic IRB (eIRB) or institutional research management systems.
Ability to maintain accurate, audit-ready, and compliant regulatory records.
Ability to effectively collaborate within multidisciplinary teams and interact professionally with study stakeholders.
Ability to prioritize tasks, manage multiple deadlines, and adapt to a fast-paced academic research environment.
Ability to follow Standard Operating Procedures (SOPs), accurately apply regulatory instructions, and execute document management workflows with moderate supervision.
Proficient in Microsoft Office Suite (Word, Excel, Outlook) and Adobe Acrobat.
Strong organizational skills and attention to detail.
Strong verbal and written communication skills.
Preferred Job Qualifications:
Experience: Research or Clinical Trials
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)
Physical Demands:
Competencies:
Willingness to learn and build regulatory expertise.
Ability to take direction, ask questions, and incorporate feedback.
Professionalism, organization, and reliability.
Disclaimer: 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.
Responsibilities:
Job Responsibilities:
Assist with the drafting and formatting of IRB applications, amendments, and continuing review submissions for assigned protocols
Incorporate IRB feedback into revised documents and route for review to support timely approval
Support submission of regulatory documents to institutional oversight committees (e.g., PRMC, Radiation Safety, IBC)
Participate in study team meetings to support the implementation of amendments, protocol changes, and safety notifications
Assist in managing version control of study documents under supervision
Maintain accurate and organized regulatory files in accordance with sponsor and institutional requirements
Support compliance documentation tracking and submission, including training logs and delegation records
Prepare files to ensure audit readiness under guidance from the supervisor
Serve as the designated regulatory contact and maintain audit-ready files throughout the study lifecycle.
Coordinate with study teams, research nurses, investigators, and sponsors to collect required documents during study start-up, study life-cycle, and study close-out
Respond to document requests and IRB communication under supervision
Participate in training on clinical research regulations, Rush SOPs, and various systems related to document receipt/management as well as submission for regulatory approvals
Stay informed of evolving clinical research, regulatory guidance, and institutional policy updates
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.