Regulatory Analyst

November 9, 2024

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University of Miami

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University of Miami is a prestigious private research university located in Coral Gables, Florida. It offers a wide range of undergraduate, graduate, and professional degree programs through its numerous schools and colleges, including the School of Architecture, College of Arts and Sciences, and Miami Herbert Business School among others. The university is recognized for its contributions to research, particularly in areas such as marine and atmospheric science through the Rosenstiel School, as well as in medicine through the Miller School of Medicine. The institution is also noted for its vibrant student life, with a strong emphasis on athletics and community engagement. University of Miami is committed to fostering an inclusive educational environment and is home to a diverse student body from around the globe.

10,000+ employees

Founded 1925

📚 Education

💰 $1M Grant on 2023-02

📋 Description

• Reviews, prepares, and provides oversight for regulatory submissions from study start-up through closure • Maintains regulatory documents to ensure compliance with applicable requirements and regulations • Oversees study submissions (initial and amendment) and regulatory document maintenance • Serves as point of contact for various boards, committees, and sponsors • Submits or assists in submission of applications for institutional clinical trials • Sends decision correspondence to appropriate parties, requesting information • Assists with drafting, preparation, and presentation of compliance programs to investigators and their staff • Ensures compliance of regulatory processes with institutional SOPs, FDA, NIH, and other regulations

🎯 Requirements

• Bachelor's Degree in relevant field • Not required, but recommended (e.g., SOCRA - CCRP) • Minimum 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 a 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

🏖️ Benefits

• medical • dental • tuition remission • more