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Transforming Lives The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.
With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value.
Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.
The Department of Medicine, Division Infectious Disease has an exciting opportunity for a Full-Time Regulatory Specialist to work on the UHealth Campus.
The Regulatory Specialist assists with the preparation and maintenance of files and binders for regulatory submissions.
Additionally, the Regulatory Specialist will prepare protocol submissions for the institutional review board and interact with study sponsors to ensure appropriate regulatory documentation for study activities.
Facilitates the process of regulatory document submissions to various boards, committees, and industry sponsors.
Supervises the collection and maintenance of credentialing information, research education records, studies, and safety reports.
Develops and maintains reporting needs and/or other requirements as established by the IRB, HSRO, and the HIPAA office Assists during audits and site visits for matters concerning regulatory documents.
Submits or assists in the submission of applications for research studies, included those federally industry, and institutionally funded.
Assists in the development, training, and education of new staff members, and in maintaining communications with study teams.
Assists in maintaining local data files.
Maintains current knowledge of applicable regulatory topics.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
MINIMUM QUALIFICATIONS Bachelor’s Degree in relevant field Minimum 1 year of relevant experience Knowledge of processes associated with clinical trials Knowledge of applicable federal, state, and local rules and regulations Ability to maintain effective interpersonal relationships Ability to communicate effectively in both oral and written form Skill in collecting, organizing and analyzing data Proficiency in computer software (i.e.
Microsoft Office, data files) Bilingual English/Spanish highly preferred Any appropriate combination of relevant education, experience and/or certifications may be considered.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida’s only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine.
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 sub-specialties, and have more than one million patient encounters each year.
Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care.
We’re the challenge you’ve been looking for.
Patient safety is a top priority.
As a result, during the Influenza (“the flu”) season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination.
Failure to meet this requirement will result in rescinding or termination of employment.
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.
Job Status: Full time Employee Type: Staff Pay Grade: c104