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. Your 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.  Your 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:

• Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers
• 150 Top Places to Work in Healthcare by Becker’s Hospital Review, 2023
• Top 10 Military Friendly® Employer, Gold Designation, 2023
• Top 10 Military Spouse Friendly® Employer, 2023