Regulatory Compliance Coordinator: Clinical Trials Core

University of Iowa; Iowa City (IA); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Paid vacation

Sick leave

Health insurance

Dental insurance

Life insurance

Disability insurance

Retirement plan contributions

Job summary

The University of Iowa's ICTS Regulatory Core seeks a Compliance Coordinator I to join its regulatory team. You will support clinical trials and research study regulatory activities, coordinate submissions to IRB and review committees, and assist with audits and regulatory interpretation.

Strong communication, organization, and attention to detail are essential. Experience with GCP and regulatory affairs, and familiarity with OnCore, REDCap, and related systems is desirable.

Qualifications

• Experience preparing submissions for IRB and other ethical applications is preferred.
• Ability to coordinate regulatory processes and document preparation for trials.
• Strong written and verbal communication and data management skills.

Responsibilities

• Investigate, remediate and report complaints and regulatory reviews.
• Coordinate sponsor interactions for on-site audits and monitor visits.
• Assist with regulatory submissions to IRB and review groups.
• Support data analysis for regulatory metrics and reporting.

Skills

Excellent written and verbal skills

Interpersonal communication

Organization and time management

Attention to detail

Regulatory affairs knowledge

Good Clinical Practice (GCP) knowledge

Proficiency with spreadsheets and DBs

Ability to handle confidential info

Tools

OnCore

eREG

REDCap

Epic

I-CART

Job description

The University of Iowa's ICTS Regulatory Core seeks a Compliance Coordinator I to join its regulatory team. You will support clinical trials and research study regulatory activities, coordinate submissions to IRB and review committees, and assist with audits and regulatory interpretation.

Strong communication, organization, and attention to detail are essential. Experience with GCP and regulatory affairs, and familiarity with OnCore, REDCap, and related systems is desirable.