Senior Regulatory Compliance Lead - Clinical Trials

University of Iowa; Iowa City (IA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Paid vacation

Health insurance

Dental insurance

Retirement contributions

Job summary

The Senior Compliance Coordinator I in ICTS at the University of Iowa will coordinate and manage regulatory activities for multiple clinical trials, including IRB submissions, adverse event reporting, and sponsor communications, to ensure strict regulatory compliance.

You will develop and implement policies, provide staff training, and maintain regulatory documentation while using systems such as OnCore, eReg, REDCap, and Epic.

Qualifications

• Experience with preparing submissions for IRB and other ethical applications (3+ years).
• Experience processing research regulatory documents (3+ years).

Responsibilities

• Monitor compliance with local, federal, institutional and sponsor requirements.
• Investigate protocol deviations and reportable events.
• Coordinate audits, monitoring visits and FDA inspections.
• Prepare regulatory submissions and maintain regulatory files.
• Develop and maintain study materials and consent documents.
• Lead or participate in regulatory trainings and policy development.

Skills

Regulatory affairs

GCP knowledge

Regulatory documentation

Project coordination

Tools

OnCore

eReg

REDCap

Epic

I-CART

CCRP Certification

Job description

The Senior Compliance Coordinator I in ICTS at the University of Iowa will coordinate and manage regulatory activities for multiple clinical trials, including IRB submissions, adverse event reporting, and sponsor communications, to ensure strict regulatory compliance.

You will develop and implement policies, provide staff training, and maintain regulatory documentation while using systems such as OnCore, eReg, REDCap, and Epic.