Regulatory Analyst 1

Responsibilities

• Prepare, submit, and ensure proper maintenance of regulatory documentation for clinical trials from study start‑up through closure.
• Facilitate the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors.
• Provide regulatory support for multiple clinical trials from study start‑up through closure.
• Generate and update essential regulatory documents, including editing consent forms appropriately based on required institutional language and/or study revisions.
• Attend site visits conducted by sponsor/Contract Research Organization (CRO) concerning regulatory documents.
• Maintain current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations) and adhere to university and department‑level policies, procedures, and safeguards University assets.
• Ensure compliance of general and study‑specific regulatory processes with SOPs, FDA, NIH, and other applicable regulations.
• 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 inclusion of required documents (Protocol Document, Consent Form(s), IND Approval or Exemption Letter, Investigator’s Brochure, Draft Budget, CTA, Patient documents, Recruitment materials, External DSMB charter).
• Assist the Sr. Regulatory Analyst (RA) in regulatory related issues.
• Ensure compliance of general and study‑specific regulatory 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, including correspondence with institutional and federal regulators, study file documentation creation and maintenance.

• 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 diverse 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.

Demonstrates expertise in regulatory documentation for clinical trials, ensuring compliance with federal, state, and local regulations while maintaining effective communication and interpersonal relationships with diverse stakeholders.