Senior Regulatory Lead, Clinical Research

Northwestern University; Chicago (IL); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Tuition benefits

Flexible work arrangements

Paid leave

Job summary

Northwestern University’s Comprehensive Transplant Center seeks an experienced Regulatory Affairs Specialist to manage regulatory oversight for studies involving human subjects. The role coordinates review and approval processes for complex clinical research across sites, ensuring participant safety, rights, and welfare, while guiding investigators on applicable rules and documentation.

The position requires interpreting CFRs and GCP guidelines, providing senior staff guidance, and training

Qualifications

• Bachelor's degree or higher required.
• Minimum of three years of experience in regulatory/medical research environment.
• Familiarity with CFRs and Good Clinical Practice guidelines.

Responsibilities

• Determines and interprets applicable rules and regulations for clinical studies involving human subjects.
• Guides submission, documentation, and reporting processes (new study applications, renewals, amendments, adverse events).
• Acts as liaison between PI, staff, and regulatory bodies (IRB, NIH, FDA, sponsors).
• Assists junior staff in resolving issues and ensuring compliance.
• Ensures accuracy of IRB approval letters and sponsor information.
• Provides training on complex regulatory requirements for clinical research.

Skills

Regulatory knowledge

Communication skills

Computer literacy

Team collaboration

Education

Bachelor's degree or higher

Job description

Northwestern University’s Comprehensive Transplant Center seeks an experienced Regulatory Affairs Specialist to manage regulatory oversight for studies involving human subjects. The role coordinates review and approval processes for complex clinical research across sites, ensuring participant safety, rights, and welfare, while guiding investigators on applicable rules and documentation.

The position requires interpreting CFRs and GCP guidelines, providing senior staff guidance, and training