Regulatory Analyst 1

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work remotely.

CORE JOB SUMMARY                                                                                                                                                                                                   

The Regulatory Analyst 1 – UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment matrix to 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

Experience:

Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.
• Ability to communicate effectively in both oral and written form.
• Ability to handle difficult and stressful situations with professional composure.
• Ability to maintain effective interpersonal relationships.
• Ability to understand and follow instructions.

Department Specifics:

Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors. Provides regulatory support for multiple clinical trials from study start-up through study closure. Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.   Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. 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 SOPs, FDA, NIH, and other applicable regulations.

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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.

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