Job Title:   Regulatory Specialist
Pay Grade:   6
Pay Band Min / Max:    - 
Position Number:   045269

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 Sylvester Comprehensive Cancer Center is seeking a Regulatory Specialist for the Phase I studies that will be responsible for assisting the Phase I Program with all aspects of regulatory submissions and compliance under the direct supervision of the Phase I Program Directors. The Phase I Regulatory Specialist will assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the University of Miami Institutional Review Board (IRB), other University committees, and the FDA as necessary including: Protocol and informed consent document initial review; Continuing Reports; Amendments and addendums to research protocols and informed consent documents; Adverse event reporting; IND submissions. Assist in gathering information from Study Coordinators, Physicians, other staff, and study sponsors as needed for the submission of regulatory documents. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.

Qualified candidate must possess a Bachelors’ degree in Biological Science, Social Sciences, English, or other related field. One year experience in an effective work-related field, including clinical trials or health care experience required. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB and FDA requirements and submissions, consent form writing, and protocol development. Computer skills including MS Office products, Internet, ad general computer proficiency required. Excellent skills in time management, prioritization, and multi-tasking required. Must complete the CITI Certification training as required. Excellent skills (both written and oral) required. Any appropriate combination of relevant education, certifications and/or work experience 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.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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