Regulatory Compliance Specialist

4 weeks ago


Miami, United States University of Miami Full time

Company Overview

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The University of Miami, a top-ranked private research university in South Florida, is seeking a highly skilled Regulatory Analyst II to join our team. Our institution is committed to excellence in teaching, research, and service.

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Salary and Benefits

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We offer a competitive salary range of $65,000 - $80,000 per year, depending on experience, as well as a comprehensive benefits package, including medical, dental, tuition remission, and more.

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Job Description

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As a Regulatory Analyst II, you will play a critical role in ensuring compliance with applicable regulatory requirements and regulations in the conduct of clinical trials. Your responsibilities will include:

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  • Reviewing and preparing regulatory submissions from study start-up through study closure;">
  • Maintaining regulatory documents to ensure compliance with applicable requirements and regulations;">
  • Providing support for the process of study submissions (initial and amendment) and regulatory document maintenance;">
  • Serving as point of contact for various boards, committees, and industry, academic, and cooperative sponsors;">
  • Submitting or assisting in the submission of applications for institutional clinical trials;">
  • Sending decision correspondence to appropriate parties, requesting information;">
  • Assisting with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance;">
  • Maintaining current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adhering to university and department-level policies and procedures and safeguards University assets;">
  • Ensuring compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations;">
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Required Skills and Qualifications

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To be successful in this role, you will need:

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  • A Bachelor's Degree in a relevant field;">
  • A minimum of two (2) years of relevant experience in fields such as compliance, research, and/or medical/clinical;">
  • IND/IDE/FDA experience preferred;">
  • Ability to maintain effective interpersonal relationships;">
  • Ability to communicate effectively in both oral and written form;">
  • Ability to utilize sound judgment, analyze problems, provides solutions and makes decisions;">
  • Skill in collecting, organizing and analyzing data;">
  • Highly organized, proactive, and detail oriented;">
  • Excellent skills in time-management, prioritization, and multi-tasking;">
  • Proficiency in computer software (i.e., Microsoft Office, Adobe Acrobat);">
  • Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers and clients;">
  • Ability to analyze, organize and prioritize work under pressure while meeting deadlines;">
  • Knowledge of processes associated with clinical trials;">
  • Knowledge of applicable federal, state, and local rules and regulations;">
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Benefits

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The University of Miami offers a comprehensive benefits package, including:

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  • Medical and dental insurance;">
  • Tuition remission;">
  • Retirement plan options;">
  • Flexible paid time off policy;">
  • Employee assistance program;">
  • Discounted rates on parking and transportation;">
  • Access to on-campus fitness facilities;">
  • Professional development opportunities;">
  • And more">
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How to Apply

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To learn more about this exciting opportunity and how to apply, please click here: https://www.myworkday.com/umiami/d/task/1422$7248.htmld

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Equal Opportunity Employer

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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.

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Job Status

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This is a full-time position.

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Pay Grade

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H9



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