Clinical Research Regulatory Lead

Medical University of South Carolina; Charleston (SC); On-site; USD 53,000 - 90,000; Full time

Job summary

The Medical University of South Carolina (MUSC) Regulatory Coordinator in the Department of Neurology supports the development, activation, and ongoing compliance of clinical research studies. This role coordinates regulatory submissions with the IRB and other oversight bodies, and ensures adherence to FDA, OHRP, HIPAA, and ICH-GCP requirements.

It provides guidance to investigators and study teams, maintains regulatory binders, tracks milestones, and supports audits and sponsor visits as part

Qualifications

• Bachelor's degree and 3 years of relevant program experience.
• Three years of clinical research, regulatory affairs, or IRB experience.
• Knowledge of FDA (21 CFR), OHRP (45 CFR 46), HIPAA, ICH-GCP guidelines.
• Experience preparing, reviewing, and submitting IRB applications, amendments, continuing reviews.

Responsibilities

• Coordinate regulatory start-up activities for new research studies (IRB submissions, amendments, monitor timelines).
• Maintain regulatory binders and electronic files per regulations and sponsor requirements.
• Provide regulatory guidance and training to investigators, coordinators, and staff.
• Support quality improvement initiatives and regulatory program development.

Skills

Regulatory knowledge

IRB submissions

Regulatory compliance

Communication

Training

Education

Bachelor's degree

Tools

IRB systems

CTMS

Electronic regulatory binders

EMR systems

Job description

The Medical University of South Carolina (MUSC) Regulatory Coordinator in the Department of Neurology supports the development, activation, and ongoing compliance of clinical research studies. This role coordinates regulatory submissions with the IRB and other oversight bodies, and ensures adherence to FDA, OHRP, HIPAA, and ICH-GCP requirements.

It provides guidance to investigators and study teams, maintains regulatory binders, tracks milestones, and supports audits and sponsor visits as part