Regulatory Specialist

Regulatory SpecialistHours of Work: 8am-5pmDays Of Week: M-FWork Shift:Job Description: 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 preferredCCRC 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 productsSuperior oral and written communication skillsStrong process orientationDetail oriented, logical, and methodological approach to problem solvingAbility to provide vision and leadershipJob Responsibilities:Communicate clearly and openlyBuild relationships to promote a collaborative environmentBe accountable for your performanceAlways look for ways to improve the patient experienceTake initiative for your professional growthBe engaged and eager to build a winning teamReview clinical research protocols to determine logistical components of regulatory requirementsObtain and facilitate tracking of relevant regulatory documents for clinical trials submission and managementMaintain appropriate communications between sponsors, investigators, other research team members for clinical trials assignedAssist in the development of clinical trial documents for signature of principal investigator and approval by the IRBCreate and/or adapt clinical trial informed consent documents for Institutional Review Board (IRB) submissionMaintain regulatory documents in accordance with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelinesAttend study specific training, investigator meetings as assigned, and MHS required trainingFacilitate informed consent process for principal and sub-investigatorsAssist 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 guidelinesPrepare and submit amendments to protocols and informed consent documents as requiredMethodist 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 2026-2027Glassdoor's Best Places to Work 2025 & 2026Glassdoor's Best Places to Work in Healthcare, Biotech & Pharma 2026TIME's Best Companies for Future Leaders 2025 & 2026Newsweek's America's Most Admired Workplaces 2026Glassdoor's Best-Led Companies 2025Fortune Best Workplaces in Health Care 2025Military Friendly Gold Employer 2025Becker's Hospital Review 150 Top Places to Work in Healthcare 2025Newsweek's Americas Greatest Workplaces 2025 Methodist Health System