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 I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure.

CORE JOB FUNCTIONS

• 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.

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 one (1) year of relevant experience in fields such as compliance, research, and/or medical/clinical.

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)
• Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers, and clients.
• Knowledge of processes associated with clinical trials.
• Knowledge of applicable federal, state, and local rules and regulations.

#LI-YC1

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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