IRB & Regulatory Lead, Clinical Research

Myana; Charleston (SC); On-site; USD 53,000 - 90,000; Full time

Job summary

The Medical University of South Carolina (MUSC) Regulatory Coordinator – Clinical Research in the Department of Neurology coordinates regulatory activities for investigator-initiated, industry-sponsored, and other human subjects research studies.

Supports start-up submissions, IRB communications, and ongoing regulatory compliance, ensuring adherence to FDA, OHRP, HIPAA, and ICH-GCP requirements across the research lifecycle.

Qualifications

• Bachelor's degree and three years of relevant program experience.
• Preferred CCRP/CCRC or equivalent certification.
• Knowledge of FDA regulations (21 CFR), OHRP, HIPAA and ICH-GCP requirements.

Responsibilities

• Regulatory start-up and IRB submissions for various study types.
• Maintain regulatory binders and electronic files per requirements.
• Provide regulatory guidance to investigators and study staff on compliance expectations.
• Prepare for sponsor monitoring visits, audits, and compliance inquiries.
• Develop and maintain regulatory tools, templates, and SOPs.

Skills

Organizational skills

Analytical skills

Written communication

Project management

Customer service

Education

Bachelor's degree in health sciences, biology, public health, nursing, clinical research or related field

CCRP/CCRC or equivalent certification

Tools

Microsoft Office

Job description

The Medical University of South Carolina (MUSC) Regulatory Coordinator – Clinical Research in the Department of Neurology coordinates regulatory activities for investigator-initiated, industry-sponsored, and other human subjects research studies.

Supports start-up submissions, IRB communications, and ongoing regulatory compliance, ensuring adherence to FDA, OHRP, HIPAA, and ICH-GCP requirements across the research lifecycle.