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The University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the Department of Research.
The Regulatory Analyst will be responsible for conducting the on-site audits, reviewing consolidated records (the results of the records once the new data are added), designing, reviewing and testing the revised treatment matrix which will identify possible cancers from claims data.
CORE JOB FUNCTIONS
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies.
Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
Provides support to investigators by reviewing submissions for content.
Sends decision correspondence to appropriate parties, requesting information.
Maintains accurate databases and generates letters.
Develops and maintains templates, creates files, and mails notices.
Adheres to University and unit-level policies and procedures and safeguards University assets.
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
Education:
Bachelor's Degree in relevant field
Any relevant education, certifications and/or work experience may be considered.
Experience:
Minimum 1 year of relevant experience
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)
Department Specific Functions
Oversees and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance
Serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors.
Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information.
Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets.
Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations.
Train study teams on the policies and procedures of the Clinical Research Services.
Maintain the regulatory and subject binders of multiple research project.
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.
