Regulatory Analyst - Remote

About the role

The University of Miami/UHealth Department of SCCC is seeking a Full Time Regulatory Analyst 1 to join our team.

Responsibilities

• Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies.
• Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
• Aids in the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
• Supports investigators by reviewing submissions for content.
• Sends decision correspondence to appropriate parties, requesting information.
• Maintains accurate databases and generates letters.
• Develops and maintains templates, creates files, and mails notices.
• Adheres to University and unit-level policies and procedures and safeguards University assets.
• Prepares and coordinates the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
• Modifies and standardizes consent forms for IRB submission is required.
• Compiles documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations.
• Prepares and maintains regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.
• Communicates with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL).
• Maintains department credentialing information and research records for clinical trials within institution’s electronic systems (e.g., Velos, Complion) and appropriate drives, as applicable.
• Participates in site visits with monitors as well as site audits concerning compliance of regulatory documents.
• Ensures timely resolution of observations identified during monitoring and auditing visits.
• Communicates with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.
• Assists in the collection and maintenance of credentialing information for study personnel (e.g., study-specific training, IBC, EHS requirements, etc.).
• Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.
• Communicates to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications.
• Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.
• Communicates with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request.
• Provides feedback to Regulatory Management on opportunities for regulatory process improvement.
• Identifies and escalates issues before they become critical.
• Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.

Qualifications

• Education: Bachelor’s degree in relevant field required.
• Experience: Minimum 1 year of relevant experience required.
• Knowledge, Skills and Abilities: Learning Agility, Teamwork, Technical Proficiency, Communication.

Benefits

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.