Clinical Research Regulatory Specialist

LCMC Health; New Orleans (LA); On-site; USD 55,000 - 85,000; Full time

Job summary

LCMC Health in New Orleans seeks a Regulatory Coordinator to manage essential study regulatory documents, prepare submissions for sponsors and the IRB, and support site visits and audits. The role requires collaboration with study teams and leadership to ensure compliance across multiple protocols.

Qualified candidates will have at least two years in clinical research, an associate degree (bachelor's preferred), and strong written/verbal communication to coordinate with IRB and sponsors.

Qualifications

• Associate degree required; research experience may count in lieu of education.
• Two years of clinical research experience required; regulatory coordination preferred.
• Strong written and verbal communication; ability to interact with IRB and sponsors.

Responsibilities

• Manage study regulatory documents (FDA Form 1572, protocol amendments, safety reports, sign logs).
• Prepare documents for sponsor/CRO submission and IRB submissions.
• Meet with leaders to discuss new and current studies.
• Assist with site visits and audits; prepare summaries and regulatory status reports.
• Maintain nursing and medical licenses on file for investigators and staff.

Skills

Attention to detail

Teamwork

Written communication

Verbal communication

Self-starter

IRB/regulatory knowledge

Education

Associate degree

Bachelor's degree

Tools

Word

Excel

Internet

Job description

LCMC Health in New Orleans seeks a Regulatory Coordinator to manage essential study regulatory documents, prepare submissions for sponsors and the IRB, and support site visits and audits. The role requires collaboration with study teams and leadership to ensure compliance across multiple protocols.

Qualified candidates will have at least two years in clinical research, an associate degree (bachelor's preferred), and strong written/verbal communication to coordinate with IRB and sponsors.