[Hiring] Regulatory Analyst 1 @University of Miami

Role Description

The Regulatory Analyst I 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 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, including editing consent forms 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) and adheres to university and department-level policies and procedures.
• 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.

Qualifications

• Bachelor's Degree in relevant field.
• Minimum one (1) year of relevant experience in fields such as compliance, research, and/or medical/clinical.
• 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.

Requirements

• Attend SDG Meetings to provide regulatory updates and guidance.
• Build and maintain a working relationship with regulatory staff and provide guidance to Regulatory Specialist (RS).
• Review protocol package for completion after PRC approval to guarantee the inclusion of required documents.
• Assist the Sr. Regulatory Analyst (RA) with regulatory related issues.
• Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations.
• Provide regulatory support for new and ongoing research studies.
• Complete new protocol submission packet with information provided by PRC.
• Communicate with study staff to ensure maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL).
• Attend required regulatory meetings.
• Update Trial Master File (TMF) for multi-center research trials.
• Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents.
• Assist with the submission of an Investigational New Drug (FDA Form 1572) application to the FDA.
• Assist in preparing regulatory documentation packets and create FDA 1572 Forms for IND filings.
• Assist PI with writing audit responses and follow-up on observation close-outs.
• Assist in maintenance of regulatory-related internal tracking databases and filing systems.
• Assist in compilation of regulatory-related metrics for use by senior management.
• Assist in the creation and maintenance of policies and procedures for the Regulatory Department.
• Ensure all necessary forms are submitted to the trial sponsor.
• Post regulatory documents to the CTMS system.
• Other duties as assigned.

Benefits

• Competitive salaries.
• Comprehensive benefits package including medical, dental, tuition remission, and more.