Clinical Research Regulatory Specialist

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

📋 Description

• Organize and maintain regulatory documents and binders systematically for monitoring and auditing during research studies.

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

• Facilitate communication with the Institutional Review Board (IRB) and/or sponsors.

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

• Distribute IND safety reports to investigators and the research team for their review.

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

• Collaborate with the research team to support protocol operations.

• Identify issues and challenges, implement corrective actions, and escalate as necessary.

• Monitor sponsor and IRB approvals and their renewals.

• Provide updates on the status of clinical trials.

• Generate and review regulatory data reports utilizing appropriate systems.

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

• Meet documentation quality standards within project and organizational timelines.

• Participate in training programs as requested.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A Bachelor’s degree along with a minimum of 2 years of experience in clinical research, or an equivalent combination of education and experience is required.

• At least 1 year of regulatory experience is preferred.

• Familiarity with GCP/ICH guidelines is essential.

• Proficient in Microsoft applications, email, electronic health records, web applications, and typing at a rate of 40+ wpm.

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

• Well-developed written and verbal communication skills.

• Strong interpersonal and listening skills.

• Capability to work both independently and collaboratively with colleagues, subjects, managers, and external customers.

• Ability to manage multiple tasks effectively and adapt to changing workloads and priorities.

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

• High level of integrity and reliability.

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

• Capacity to handle highly sensitive information confidentially and professionally, in accordance with HIPAA guidelines.

🏝️ 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 their hire date.

• Benefits include medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match.