Florida Licensed Regulatory Affairs Lead

Job Summary

To support a growing clinical research network, the fully remote Florida Licensed Regulatory Affairs Lead will manage study-level regulatory aspects of clinical trials, ensuring compliance with regulatory and quality requirements while coordinating with multiple sites.

Key responsibilities

• Proactively manages regulatory aspects of clinical trials, including feasibility, study start-up, and close-out activities
• Leads the study start-up process by preparing and filing essential regulatory documents, reviewing informed consents, and coordinating site initiation visits
• Maintains Investigator Site Files (ISFs) and ensures compliance with Good Clinical Practice (GCP) and regulatory requirements

Required qualifications

• Bachelor's degree in Business or Health Science preferred or equivalent experience
• 4-6 years of hands-on experience in clinical research with a strong understanding of study operations and protocols
• Proven expertise in regulatory affairs and compliance with clinical research guidelines
• Knowledge of Good Clinical Practice (GCP), IATA, and FDA regulations
• Ability to multitask and manage a high volume of studies effectively