Job Title: Research Regulatory Supervisor

Work Location: Pinellas County, FL

Summary:

Seeking a Research Regulatory Supervisor to oversee a team responsible for regulatory submissions and compliance in clinical research. This role involves leadership, regulatory oversight, and ensuring adherence to all applicable regulations and guidelines for human subject research projects.

Responsibilities:

• Supervise a team of regulatory specialists, ensuring all clinical research activities comply with relevant regulations and guidelines.
• Oversee the preparation and submission of regulatory documents to local and central Institutional Review Boards (IRBs).
• Coordinate regulatory oversight for human subjects research projects, including registration and documentation requirements.
• Manage the submission of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications to regulatory authorities as needed.
• Ensure operational efficiency and regulatory compliance through effective leadership and team management.
• Facilitate communication and collaboration among research teams to support protocol adherence and regulatory standards.
• Utilize strong analytical and problem-solving skills to address regulatory challenges and streamline processes.
• Maintain up-to-date knowledge of FDA regulations and human subject protection requirements, providing guidance and training to staff as necessary.

Qualifications:

• Bachelor's degree in Business, Healthcare Management, or a related field required.
• Minimum of 3 years of experience in research regulatory submissions required.
• Extensive knowledge of FDA regulations and human subject protection standards.
• Demonstrated leadership and team management abilities.
• Strong operational oversight, communication, and collaboration skills.
• Excellent analytical and problem-solving capabilities.
• Preferred certifications: SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research Professionals), or CCRC (Certified Clinical Research Coordinator).

Published Category: Regulatory Affairs