Clinical Trials Regulatory Lead

METHODIST MANSFIELD MEDICAL CENTER; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Methodist Mansfield Medical Center is seeking a Regulatory Specialist in Dallas, TX to lead regulatory activities for phase II/IV clinical trials, IITs, and retrospective analyses. The role emphasizes high attention to detail, strong communication, and leadership in a regulatory context.

Responsibilities include IRB coordination, regulatory document management, and collaboration with sponsors and investigators to ensure compliance with ICH and GCP guidelines.

Qualifications

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

Responsibilities

• Review clinical research protocols to determine regulatory requirements.
• Maintain regulatory documents in accordance with ICH and GCP guidelines.
• Coordinate IRB submissions and approvals for trials.
• Assist in development of informed consent documents for IRB submission.
• Communicate with sponsors, investigators and study team to ensure regulatory compliance.

Skills

MS Office

Strong communication

Attention to detail

Problem solving

Leadership

Regulatory affairs knowledge

Education

Bachelor's degree

Master’s degree

CCRC/CCRP certification

GCP certification

Tools

Microsoft Office Suite

IRB submission systems

Job description

Methodist Mansfield Medical Center is seeking a Regulatory Specialist in Dallas, TX to lead regulatory activities for phase II/IV clinical trials, IITs, and retrospective analyses. The role emphasizes high attention to detail, strong communication, and leadership in a regulatory context.

Responsibilities include IRB coordination, regulatory document management, and collaboration with sponsors and investigators to ensure compliance with ICH and GCP guidelines.