Clinical Research Regulatory Coordinator II

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

Job summary

Medical University of South Carolina in Charleston seeks a Regulatory Coordinator for the Neurology department to oversee regulatory activities. You will coordinate study start-up, manage IRB submissions, and ensure ongoing compliance across diverse research projects.

You will maintain regulatory documentation, support audits, and mentor staff on regulatory requirements, policies, and best practices within a dynamic academic medical center.

Qualifications

• Bachelor's degree in health sciences or related field and 3+ years in regulatory affairs or clinical research.
• Experience preparing, reviewing, and submitting IRB applications and amendments.
• Knowledge of FDA, OHRP, HIPAA, and ICH-GCP guidelines.

Responsibilities

• Coordinate regulatory start-up activities for new research studies across various funding sources.
• Prepare, review, and submit IRB applications and related documents.
• Maintain regulatory binders and electronic files per requirements.
• Monitor regulatory milestones and ensure timely approvals and renewals.
• Assist with sponsor monitoring visits, audits, and compliance inquiries.
• Identify regulatory risks and propose corrective actions.

Skills

Regulatory knowledge

IRB coordination

Clinical research

Regulatory submissions

Project management

Education

Bachelor's degree in health sciences or related field

Tools

IRB systems

Clinical trial management systems

Electronic regulatory binders

MS Office

Job description

Medical University of South Carolina in Charleston seeks a Regulatory Coordinator for the Neurology department to oversee regulatory activities. You will coordinate study start-up, manage IRB submissions, and ensure ongoing compliance across diverse research projects.

You will maintain regulatory documentation, support audits, and mentor staff on regulatory requirements, policies, and best practices within a dynamic academic medical center.