Clinical Trials Regulatory Coordinator (IRB & Audits)

PeopleAdmin, Inc.; New Orleans (LA); On-site; USD 60,000 - 80,000; Full time

Job summary

LSU Health New Orleans is seeking a Regulatory Coordinator to oversee regulatory activities for the Cancer Center Clinical Trials Office. The role includes processing IRB, RRC, CTRC, and external regulatory submissions, while maintaining credentialing for site investigators and research staff.

The incumbent will monitor updates, draft consents, assist with new protocols, manage adverse event forms, and prepare records for audits in a dynamic, high‑pressure environment.

Qualifications

• Bachelor's degree required.
• Three years of related work experience.
• Experience with IRB submissions preferred.
• Knowledge of regulatory requirements for NCI, industry-sponsored protocols.

Responsibilities

• Supervise all regulatory activities and process/submission of documents to IRB/ RRC/CTRC and regulators.
• Maintain credentialing for investigators and research staff across sites.
• Monitor regulatory broadcasts and disseminate updates to the team.
• Write informed consents and facilitate new protocol submissions.
• Prepare regulatory records for site audits and respond to inquiries.

Skills

Regulatory coordination

Clinical trials experience

Documentation management

Attention to detail

Time management

Education

Bachelor's degree

Job description

LSU Health New Orleans is seeking a Regulatory Coordinator to oversee regulatory activities for the Cancer Center Clinical Trials Office. The role includes processing IRB, RRC, CTRC, and external regulatory submissions, while maintaining credentialing for site investigators and research staff.

The incumbent will monitor updates, draft consents, assist with new protocols, manage adverse event forms, and prepare records for audits in a dynamic, high‑pressure environment.