Clinical Research Regulatory Coordinator - Research Affairs-Full-time - Hybrid

Job Description

Location: Chicago, Illinois

Business Unit: Rush Medical Center

Hospital: Rush University Medical Center

Department: Research Affairs-ResAdm

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

Shift: Shift 1

Work Schedule: 8 Hr (7:00:00 AM - 3:00:00 PM)

Rush offers exceptional rewards and benefits learn more at our Rush benefits page (

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.

Job Summary:

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.

Other information:

Required Job Qualifications:

Education: Bachelor’s degree or equivalent

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

Knowledge, Skills, & 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.

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.

Preferred Job Qualifications:

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

Physical Demands:

Competencies:

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.

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:

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., PRMC, Radiation Safety, IBC) and track approvals to support study activation.

Manage regulatory activities for multiple clinical research studies, including cooperative group, single-site, industry-sponsored, and investigator-initiated trials.

Coordinate regulatory start-up by gathering, reviewing, and distributing documents needed for IRB, budget, contract, and coverage analysis processes.

Implement protocol amendments and maintain version control; coordinate updates with study teams and ensure compliance with the latest protocol and safety documents.

Prepare and update submission documents across the study lifecycle, ensuring alignment with institutional and sponsor requirements.

Serve as the designated regulatory contact and maintain audit-ready files throughout the study lifecycle.

Maintain detailed and up-to-date regulatory records that reflect protocol activity, compliance events, and IRB approvals.

Follow established SOPs and document regulatory actions in alignment with institutional, sponsor, and regulatory agency requirements.

Communicate study status updates and respond to stakeholder questions; prepare summary reports for investigators, sponsors, and institutional contacts as needed.

Assist with regulatory compliance tracking and monitor submission deadlines and approvals within the department.

Prepare and maintain compliance documents for departmental and institutional review, ensuring timely submission and recordkeeping.

Facilitate timely investigator review of safety reports and document assessments as required.

Recommend improvements to enhance compliance and workflow efficiency.

Collaborate with the study team to identify and report protocol deviations and assist in developing corrective and preventive actions (CAPAs).

Support onboarding by sharing regulatory tools, procedures, or guidance with new staff or study teams.

Stay informed of current regulatory guidance, GCP updates, and industry best practices.

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.

Position Clinical Research Regulatory Coordinator - Research Affairs-Full-time - Hybrid

Location US:IL:Chicago

Req ID 26244