Regulatory Analyst 1

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🔥 0 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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University of Miami

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1925

📚 Education

💰 $1M Grant on 2023-02

Education

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.

📋 Description

• Prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. • Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions. • Provides regulatory support for multiple clinical trials from study start-up through study closure. • Generates and updates essential regulatory documents 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. • Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

🎯 Requirements

• Bachelor's degree in relevant field • Minimum 2 years Regulatory Affairs experience in the clinical research industry or equivalent combination of studies and relevant work experience inclusive of substantial experience in regulatory affairs. • 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.

🏖️ Benefits

• medical • dental • tuition remission • competitive salaries