Regulatory Specialist
University Of Miami Miller School Of Med - Miami, FL

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The University of Miami Miller School of Medicine-UHealth is home to some of the brightest minds in the world. Our Faculty teach students who represent the future of medicine. Our researchers are discovering breakthrough patient treatments. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties, and have more than one million patient encounters each year.

The University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center is seeking a Regulatory Specialist who will be responsible assisting the Clinical Research Coordinator (CRC) with aspects of regulatory submissions. Individual will assist the CRCs in preparing regulatory submissions and maintaining the regulatory files and binders (Trial Master File). Responsible for processing of regulatory document submission to the FDA for investigator held IND studies. Assist the Protocol Development Specialist and the CRC in the aspects of protocol development related to regulatory issues. Prepare and submit new clinical trials through the Site Disease Group, Protocol Review Committee, and Investigational Review Board process leading to new trial opening. Maintain the Trial Master File (TMF). Maintenance of FDA related submissions to the FDA for investigator held IND studies. Supervise the collection and maintenance of credentialed information including Principal Investigator and study team training records, curriculum vitae, and research education records.

Bachelor’s degree and one year of experience or in lieu of degree six years in an effective work-related field including clinical trials or other research related areas. Working knowledge of clinical trials, Federal, State and Local Regulations, ICH-GCP and FDA Guidance, IRB requirements and submissions, consent form writing, and protocol development. Computer skills including MS Office products, Internet, and general computer proficiency required. Excellent skills in time management, priorization, and multi-tasking required. Any appropriate combination of relevant education, experience and/or certification will be considered.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. University of Miami Hospital is the flagship facility of UHealth, which also includes the Sylvester Comprehensive Cancer Center and Bascom Palmer Eye Institute, along with dozens of outpatient facilities. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.