Clinical Research Regulatory Specialist

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

📋 Description

• Organize and maintain regulatory documents and binders in a systematic, audit-ready manner throughout the lifecycle of studies.

• Adhere to organizational SOPs and offer guidance to ensure staff understanding and compliance.

• Facilitate effective communication with IRBs and sponsors.

• Assist in coordinating the development of clinical trial support documents and regulatory submissions.

• Distribute IND safety reports for review by investigators and research teams.

• Assemble, reproduce, and archive technical documents in both hard-copy and electronic formats.

• Collaborate with research teams to support protocol operations.

• Identify issues and challenges, take corrective actions, and escalate matters when necessary.

• Track approvals and renewals from sponsors and IRBs.

• Provide updates on the status of clinical trials.

• Generate and review regulatory data reports using appropriate systems.

• Ensure that assigned tasks meet federal regulations and ICH/GCP standards.

• Achieve documentation quality standards within project timelines and company expectations.

• Assist with training programs upon request.

• Carry out other assigned duties.

⛳️ Requirements

• A Bachelor’s degree and a minimum of 1 year of experience in clinical research regulatory, or an equivalent combination of education and experience, is required.

• Knowledge of GCP/ICH guidelines is essential.

• Proficiency in Microsoft applications, email, electronic health records, and web applications.

• Ability to type proficiently (40+ wpm).

• Strong organizational abilities, attention to detail, and basic mathematical skills.

• Well-developed written and verbal communication skills.

• Strong interpersonal and listening skills.

• Ability to work independently as well as collaboratively with co-workers, subjects, managers, and external customers.

• Capability to effectively manage multiple tasks and adapt to varying workloads and priorities.

• Professionalism, respect for others, self-motivation, and a robust work ethic.

• A high degree of integrity and reliability.

• Ability to work with minimal supervision, identify issues, and assist in implementing solutions.

• Capacity to manage highly sensitive information confidentially and professionally, in compliance with HIPAA regulations.

🏝️ Benefits

• Full-time employees scheduled to work at least 30 hours per week are eligible for benefits, with coverage commencing on the first day of the month following the date of hire.

• Medical, dental, vision, life insurance, and short and long-term disability insurance.

• Health savings accounts.

• Supplemental insurances.

• 401k plan with a safe harbor match.