Regulatory Specialist I

A Regulatory Specialist I works closely with our Clinical Research sites to ensure the integrity and accuracy of all
regulatory documentation within the organization.

DUTIES & RESPONSIBILITIES

• Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions
• Follows up, communicates, and facilitates responses to queries of the IRB, Sponsor, and other committee as a result of their review of submissions
• Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research
• Perform regulatory binder maintenance and quality control checks
• Participates in quality assurance (QA) and control programs related to the overall project and regulatory compliance
• Any other tasks as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

• Associates degree, required
• Bachelor's degree, preferred

Experience:

• FDA, IRB administration, research, and regulatory affairs familiarity
• 12 months of clinical research experience

Credentials:

• N/A

Knowledge and Skills:

• Strong written and oral communication skills.
• Strong computer skills, including Microsoft Office, Excel, and PowerPoint.
• Ability to manage time-sensitive projects in order to meet deadlines.
• Strong ability to establish and maintain effective working relationships.