Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Develops and manages a document management system for electronic regulatory files.

• Ensures the maintenance of FDA and GCP mandated regulatory documentation for various sites, studies, sponsors, and/or other networks.

• Verifies that all regulatory documentation adheres to local Standard Operating Procedures (SOPs) regarding format and content.

• Keeps essential documentation up to date to ensure compliance.

• Revises and/or creates informed consent forms, while updating and managing modifications or amendments to protocols, investigator drug brochures, and consent forms in accordance with IRB policy and HIPAA regulations.

• Organizes and prepares documentation for IRB submissions across multiple trials.

• Handles Protocol Deviations that qualify for IRB reporting criteria.

• Sends urgent safety notifications to the IRB.

⛳️ Requirements

• An Associate's Degree or higher is preferred; a high school diploma is required. Relevant experience may replace educational qualifications.

• A minimum of 1 year of experience in clinical research, pharmaceuticals, or site management organizations is highly desired, with a focus on regulatory affairs.

• Familiarity with medical terminology, FDA regulations, and other regulatory processes is strongly preferred.

🏝️ Benefits

• Comprehensive benefits designed to promote physical, mental, and financial well-being.