REGULATORY SPECIALIST - CRI

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

Hours of Work : 8am-5pm Days Of Week : M-F Work Shift : Job Description : Your Job:

The Regulatory Specialist will perform expertise in the regulatory component of all clinical research trials to include, but not limited to; Phase II and IV clinical, investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, vision, values, and strategies of the Methodist Health System.

Job Requirements:

• 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
• Superior oral and written communication skills
• Strong process orientation
• Detail oriented, logical, and methodological approach to problem solving
• Ability to provide vision and leadership.

Job Responsibilities:

• Communicate clearly and openly
• Build relationships to promote a collaborative environment
• Be accountable for your performance
• Always look for ways to improve the patient experience
• Take initiative for your professional growth
• Be engaged and eager to build a winning team
• Review clinical research protocols to determine logistical components of regulatory requirements
• Obtain and facilitate tracking of relevant regulatory documents for clinical trials submission and management.
• Maintain appropriate communications between sponsors, investigators, other research team members for clinical trials assigned.
• Assist in the development of clinical trial documents for signature of principal investigator and approval by the IRB.
• Create and/or adapt clinical trial informed consent documents for Institutional Review Board (IRB) submission.
• Maintain regulatory documents in accordance with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
• Attend study specific training, investigator meetings as assigned, and MHS required training.
• Facilitate informed consent process for principal and sub-investigators.
• Assist clinical research coordinators in the identification and reporting of appropriate adverse events in accordance with Food and Drug Administration, sponsor protocol, and IRB regulations and guidelines.
• Prepare and submit amendments to protocols and informed consent documents as required.

Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare, Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we’ve earned: Great Place to Work Certified 2026-2027 Glassdoor’s Best Places to Work 2025 & 2026 Glassdoor’s Best Places to Work in Healthcare, Biotech & Pharma 2026 TIME’s Best Companies for Future Leaders 2025 & 2026 Newsweek’s America’s Most Admired Workplaces 2026 Glassdoor’s Best-Led Companies 2025 Fortune Best Workplaces in Health Care 2025 Military Friendly Gold Employer 2025 Becker’s Hospital Review 150 Top Places to Work in Healthcare 2025 Newsweek’s Americas Greatest Workplaces 2025