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The department of Medicine, division of Pulmonary Medicine, 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, binders, and required program documentation for regulatory submissions.

CORE JOB FUNCTIONS

Facilitates the process of regulatory document submissions to various boards, committees, industry sponsors, and state and federal agencies. Collects and maintains credentialing information, research education records, studies, safety reports, and other required program documentation. Assists during audits and site visits for matters concerning regulatory compliance. Submits or assists in the submission of applications for institutional clinical trials, state and/or federal programs, and grants. Assists in the development, training, and education of staff members.Maintains current knowledge of applicable regulatory topics.Adheres to University and unit-level policies and procedures and safeguards University assets.

Department Specific Functions

Prepare, review, and submit all regulatory documents, including Institutional Review Board submissions, amendments, continuing reviews, and safety reports.Ensure compliance with local, state, and federal regulations (FDA, NIH, ICH-GCP) and institutional policies.Oversee regulatory start-up activities for new clinical trials, including site feasibility assessments and submission of site initiation packages.Manage regulatory close-out activities, ensuring final reporting to IRB and sponsorsDevelop and update SOPS to streamline regulatory workflows and enhance to compliance

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.

CORE QUALIFICATIONS

Bachelor’s Degree in relevant fieldMinimum 1 year of relevant experience1 Year experience working with the Institutional review Board (IRB) highly desired

Knowledge, Skills and Attitudes:

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).

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.

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:

H7