REGULATORY COORDINATOR

Louisiana State University Health Sciences Center Portal; 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

The LSU Cancer Center has an opening for a Regulatory Coordinator to work with the Cancer Center Clinical Trials Office (CC- CTO ). The Regulatory Coordinator will be responsible for supervising all regulatory activities and processing and submitting all documentation related to the Institutional Review Board ( IRB ), Research Review Committee ( RRC ), Clinical Trials Research Center ( CTRC ), and pharmaceutical company regulatory mandates as required for NCI , industry-sponsored, and investigator-initiated protocols. The Regulatory Coordinator must also maintain credentialing for all Cancer Center, partner, and contracted affiliate site Investigators and Research Associates through the NCI and related cooperative groups. Duties include monitoring Cooperative Group/Pharmaceutical broadcasts for updates, maintaining electronic and paper files for dissemination, writing consents, facilitating and processing new protocols, completing and submitting adverse event forms, preparing regulatory records for all site audits, and other duties as assigned.

The selected candidate must be organized, possess good decision making, problem solving, time management, and organization skills while maintaining attention to detail and flexibility in a high pressure environment as demands change.

Additional Position Information

Minimum Qualifications

Required Education

Required Education Bachelor's

If Other Required Education, please specify

Discipline(s) Unspecified

Certifications/Licenses Required

Indicate the minimum number of years required to do the job

Indicate the minimum number of years required to do the job Three

Indicate the type of experience required to do the job

Indicate if any combination of specific experience, training and education may be substituted for the required education or experience

Master’s degree can substitute for 2 years of work experience

Preferred Qualifications

Preferred Education

Preferred Education Bachelor's

If Other Preferred Education, please specify

Discipline(s) Basic or Health Science related

Certifications/Licenses Preferred

Indicate the preferred experience to perform the job

Indicate the preferred experience to perform the job Regulatory submission and/or clinical trials experience

Posting Number

Posting Number U01195P

Number of Vacancies

Number of Vacancies 1

Desired Start Date

Position End Date (if temporary)

Posting Close Date

Open Until Filled Yes

Application Review Date to Begin

Special Instructions Summary

EEO Statement

LSU Health New Orleans is committed to leveraging diversity as an educational resource and an institutional core value. We seek candidates who will contribute to a climate where students, faculty, and staff of all identities and backgrounds have equitable access and success opportunities. As an equal opportunity, affirmative action employer, we welcome all to apply without regard to race, color, religion, age, sex, national origin, physical or mental disability, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

About the School/Department

Supplemental Questions

Required fields are indicated with an asterisk (*).

• * Which of the following best describes your earned degree and work experience or will by start date?
  • Bachelor's Degree and three (3) years' work experience
  • A least a Master's Degree and one (1) year work experience
  • None of the above