Under the direct supervision of the Clinical Research Institute (CRI) Director 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.
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.
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.
Dallas-based Methodist Health System has been recognized by Modern Healthcare as one of the fastest-growing health systems in the U.S. Over the past decade, our nonprofit health system has tripled in size. Ten hospitals proudly carry the Methodist name as part of Methodist Health System or through joint-venture affiliations. Soon our 11th hospital will open in Midlothian. Our wholly owned, full-service facilities and physician organization include Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers; Methodist Campus for Continuing Care; and Methodist Medical Group, the physician organization affiliated with Methodist Health System. We're proud to be the first member of the Mayo Clinic Care Network in Texas, where we collaborate with a national leader in healthcare to improve the delivery of care through shared medical knowledge and research. Professionals thrive at Methodist, which is why we've earned:
A Best Place to Work 15 years running by the Dallas Business Journal
150 Great Places to Work in Healthcare by Becker's Hospital Review eight years in a row.
In 2018, ranked No. 2 Top Hospitals and Health Systems in America by DiversityInc.