Regulatory Research Assistant

Job Description

JOB DETAILS

REQUIREMENTS

• Bachelor’s degree in a scientific, health-related, or administrative field preferred; equivalent experience considered.
• Prior experience in clinical research, regulatory affairs, or related field preferred but not required.
• Knowledge of ICH-GCP, FDA, and IRB regulations are desirable.
• Exceptional attention to detail and outstanding organizational skills, with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks simultaneously.

RESPONSIBILITIES

• Provide administrative and organizational support to regulatory staff.
• Assist with preparation, organization, and distribution of study-related documents.
• Help maintain regulatory files and electronic systems to ensure records are accurate, complete, and audit-ready.
• Support the submission process to Institutional Review Boards (IRBs), including assisting with renewals and updates.
• Track staff training and certification records to ensure compliance.

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