Regulatory Lead, Clinical Trials & Compliance

Methodist-Health-System; Dallas (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Methodist Health System is seeking a Regulatory Specialist to oversee regulatory aspects of Phase II/IV clinical trials, IITs, and retrospective analyses. You will review protocols, prepare regulatory documents, and facilitate IRB submissions while ensuring compliance with ICH and GCP guidelines.

The role requires at least one year in clinical research and medical settings, plus strong Microsoft Office skills and excellent communication. Dallas-based, with a mission-driven healthcare focus.

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).
• Strong proficiency using Microsoft Office products.

Responsibilities

• Review clinical trial protocols to determine regulatory requirements and logistics.
• Maintain communications between sponsors, investigators, and the research team.
• Assist in developing regulatory documents and IRB submissions.
• Ensure regulatory documents comply with ICH and GCP guidelines.
• Attend study trainings and investigator meetings as required.
• Support adverse event reporting and protocol amendments.

Skills

MS Office

Oral & written communication

Process orientation

Attention to detail

Problem solving

Leadership

Education

Bachelor's degree

Master’s degree

CCRC

GCP certification

Job description

Methodist Health System is seeking a Regulatory Specialist to oversee regulatory aspects of Phase II/IV clinical trials, IITs, and retrospective analyses. You will review protocols, prepare regulatory documents, and facilitate IRB submissions while ensuring compliance with ICH and GCP guidelines.

The role requires at least one year in clinical research and medical settings, plus strong Microsoft Office skills and excellent communication. Dallas-based, with a mission-driven healthcare focus.