IRB & Regulatory Coordinator, Clinical Trials

Northwestern University; Chicago (IL); On-site; USD 35,000 - 66,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

Paid Vacation & Holidays

Sick Leave & Parental Leave

Tuition Benefits

Pre-tax and Flex Spending Accounts

Retirement Savings Options

Wellness Programs

Job summary

Northwestern University is seeking a Regulatory/IRB support role to assist with IRB submissions for new and revised studies. The position serves as a regulatory liaison among research staff, principal investigators, sponsor companies, and the IRB, ensuring compliance with NU-, local-, state-, and federal regulations.

The role involves preparing IRB submissions, coordinating renewals and modifications, and supporting data management and study documentation across various clinical research

Qualifications

• Bachelor's degree knowledge or equivalent combination of experience.
• Experience with regulatory submissions and documentation is preferred.
• Strong communication and liaison abilities with research staff, PI, sponsor, and IRB.

Responsibilities

• Assists PI's in gaining IRB approval for new protocols involving minimal risk by submitting via eIRB system.
• Acts as a liaison between research staff and the IRB; coordinates sponsor, PI, and IRB communications.
• Assists in drafting study protocols, informed consent templates, and IRB approval letters with sponsor info and NIH identifiers.
• Maintains study binders and documentation to ensure compliance with applicable regulations and supports data management.
• Assists with IND submissions and renewals; communicates with the FDA as needed.

Skills

Attention to Detail

Organization

Education

Bachelor's degree or equivalent combination of experience

Job description

Northwestern University is seeking a Regulatory/IRB support role to assist with IRB submissions for new and revised studies. The position serves as a regulatory liaison among research staff, principal investigators, sponsor companies, and the IRB, ensuring compliance with NU-, local-, state-, and federal regulations.

The role involves preparing IRB submissions, coordinating renewals and modifications, and supporting data management and study documentation across various clinical research