Clinical Trials Regulatory Specialist

Methodist Health System; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

The Regulatory Specialist position at Methodist Health System in Dallas, TX focuses on the regulatory components of clinical trials, including Phase II/IV trials, IITs, and retrospective data analysis. This role supports organization goals and ensures compliance with ICH-GCP guidelines.

You will coordinate IRB submissions, maintain essential regulatory documents, and facilitate the informed consent process while collaborating with study teams to protect patient safety and data integrity.

Qualifications

• Bachelor's degree in a related field required; Master’s preferred.
• Experience in clinical research and regulatory affairs required.
• GCP certification preferred; strong documentation skills.

Responsibilities

• Review clinical research protocols for regulatory requirements.
• Coordinate regulatory submissions and IRB approvals.
• Maintain regulatory documents per ICH-GCP standards.
• Support informed consent processes with study teams.
• Communicate with sponsors, investigators, and coordinators.
• Identify and report adverse events per FDA guidelines.

Skills

Regulatory affairs

Clinical research

GCP certification

IRB submissions

Documentation and record-keeping

Communication skills

Education

Bachelor's degree

Master’s degree preferred

Tools

Microsoft Office

Job description

The Regulatory Specialist position at Methodist Health System in Dallas, TX focuses on the regulatory components of clinical trials, including Phase II/IV trials, IITs, and retrospective data analysis. This role supports organization goals and ensures compliance with ICH-GCP guidelines.

You will coordinate IRB submissions, maintain essential regulatory documents, and facilitate the informed consent process while collaborating with study teams to protect patient safety and data integrity.