Regulatory Analyst 1

University of Miami•Miami, FL

1d•Onsite

About The Position

The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. This role provides regulatory support for multiple clinical trials, generates and updates essential regulatory documents, and ensures compliance with applicable regulations and institutional policies. The position requires maintaining current knowledge of regulatory topics and attending site visits for regulatory matters.

Requirements

Bachelor's Degree in a 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 a 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.
Bachelor's degree.
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.
Good verbal and written communication and organizational skills.
Ability to work well with a fast-paced team of study personnel (PI, data and clinical).
Ability to manage multiple tasks simultaneously and independently.
Experience with computer systems and software, including databases, spreadsheets, and word processing.
Experience with Microsoft Office software.
Familiarity with clinical research protocols including human subjects’ applications and informed consent documents.
Ability to maintain patient confidentiality.
Familiarity with medical terminology.

Responsibilities

Prepares, submits, and maintains regulatory documentation for clinical trials.
Provides regulatory support for multiple clinical trials from study start-up through study closure.
Generates and updates essential regulatory documents, including editing consent forms.
Attends site visits conducted by sponsor/Contract Research Organization (CRO) for regulatory document matters.
Maintains current knowledge of applicable regulatory topics and adheres to university and department policies.
Ensures compliance of regulatory processes with SOPs, FDA, NIH, and other applicable regulations.
Attends SDG Meetings to provide regulatory updates and guidance.
Builds and maintains a working relationship with regulatory staff and provides guidance to Regulatory Specialist (RS).
Reviews protocol package for completion after PRC approval.
Assists the Sr. Regulatory Analyst (RA) in regulatory-related issues.
Ensures compliance with SOPs, FDA, NIH, and applicable regulations for reporting events to regulatory agencies.
Provides regulatory support for new and ongoing research studies, including correspondence with regulators and study file maintenance.
Completes new protocol submission packets and modifies/standardizes consent forms for IRB submission.
Communicates with study staff to ensure maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL).
Ensures all subsequent training is completed for study personnel and documentation is maintained in the regulatory binder.
Attends required regulatory meetings.
Updates Trial Master File (TMF) for multi-center research trials.
Communicates with the sponsor and/or contract research organization for completion and submission of regulatory documents.
Communicates to the Regulatory Manager relevant aspects of the regulatory process that need improvement.
Assists with the submission of an Investigational New Drug (FDA Form 1572) application to the FDA.
Assists in preparing regulatory documentation packets and creates FDA 1572 Forms for IND filings.
Assists PI with writing audit responses and follow-up on observation close-outs.
Assists in maintenance of regulatory-related internal tracking databases and filing systems.
Assists in compilation of regulatory-related metrics for use by senior management.
Assists in the creation and maintenance of policies and procedures for the Regulatory Department (e.g. SOPs).
Ensures all necessary forms are submitted to the trial sponsor.
Posts regulatory documents to the CTMS system.
Performs other duties as assigned.