Regulatory Analyst 1 - Remote

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.
• Safeguards compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

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.

DEPARTMENT SPECIFICS

Duties & Responsibilities

• 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 has been granted to guarantee the following documents are included: Protocol DocumentConsent Form(s)IND Approval or Exemption LetterInvestigator’s BrochureDraft BudgetCTAPatient documents (if applicable)Recruitment materials (if applicable)External DSMB charter (if applicable)
• Afford the Sr. Regulatory Analyst (RA) in the aspects of regulatory related issues. Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
• Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance. Completion of the new protocol submission packet with the information provided by PRC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.).
• Modifying and standardizing consent forms for IRB submission is required. In addition, must follow the entire initial submission process until the new study is approved.
• Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL). Ensure in conjunction with the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• 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 via inter-links, regular mail, or email. This responsibility is sponsor-dependent. The following documents may be included: Financial Disclosure FormsFDA 1572Initial Protocol Signature PageAmendments signature pageInvestigators CV and Medical LicensesLaboratories normal ranges and certificationsIRB approvalsApproved consentsOther documents as required by the sponsor
• Communicate to the Regulatory Manager relevant aspects of the regulatory process that need improvement.
• Aid in the submission of an Investigational New Drug (FDA Form 1572) application to the FDA for institutional clinical trials.
• Aid in preparing regulatory documentation packets and create FDA 1572 Forms for IND filings.
• Aid PI with writing audit responses and follow-up on observation close-outs.
• Aid in maintenance of regulatory-related internal tracking databases and filing systems.
• Aid in compilation of regulatory-related metrics for use by senior management.
• Aid in the creation and maintenance of policies and procedures for the Regulatory Department (e.g. SOPs) as well as preparing PowerPoint presentations for SOP implementation and/or training.
• Ensure all necessary forms are submitted to the trial sponsor.
• Post regulatory documents including protocols, amendments, consent forms and safety reports to the CTMS system.

Requirements

• Requirements include Bachelor's degree and 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.

Skills

• 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.

DEPARTMENT SPECIFICS

Education & Experience

• 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.

Benefits

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

About the University of Miami

• The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff