Regulatory Specialist — Clinical Trials & Compliance Lead

Methodist Health; Dallas (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Methodist Health is seeking a Regulatory Specialist to oversee regulatory aspects of clinical trials, including Phase II/IV, IITs, and retrospective analyses. You will ensure compliance with ICH/GCP, manage IRB interactions, and support trial documentation.

The role requires a Bachelor's degree, experience in clinical research, and strong communication skills; CCRP/CCRC and GCP certification are preferred. This on-site Dallas position offers a collaborative team and opportunities for

Qualifications

• Bachelor's degree required; Master’s degree preferred.
• CCRC or CCRP preferred.
• GCP certification preferred.
• 1 year of experience in a medical or clinical setting (required).
• 1 year of experience in clinical research (required).
• 1 year of experience in research regulatory affairs (required).

Responsibilities

• Review clinical research protocols to determine regulatory requirements.
• Obtain and track regulatory documents for trial submissions and management.
• Maintain communications between sponsors, investigators, and the research team.
• Assist in developing clinical trial documents for IRB approval.
• Coordinate informed consent processes and amendments as required.

Skills

Regulatory affairs

Clinical research

GCP knowledge

Communication skills

Detail oriented

Education

Bachelor's degree

Master's degree

CCRC or CCRP

GCP certification

Tools

Microsoft Office

Job description

Methodist Health is seeking a Regulatory Specialist to oversee regulatory aspects of clinical trials, including Phase II/IV, IITs, and retrospective analyses. You will ensure compliance with ICH/GCP, manage IRB interactions, and support trial documentation.

The role requires a Bachelor's degree, experience in clinical research, and strong communication skills; CCRP/CCRC and GCP certification are preferred. This on-site Dallas position offers a collaborative team and opportunities for