Research Quality Assurance and Compliance Specialist

VANCE THOMPSON VISION CLINIC PROF L • Omaha, NE

5d • Onsite

About The Position

At Vance Thompson Vision, we are seeking a Research and Regulatory Compliance Specialist to join our growing team. This role is crucial for maintaining our position as global leaders in vision correction through groundbreaking research, innovative technology, and exceptional patient care. We are looking for an individual who embodies our core values of Caring, Fun, Commitment, Egalitarianism, and Excellence. The ideal candidate is detail-oriented, a critical thinker, a clear communicator, an independent learner, and a problem solver.

Requirements

• A Clinical Research Coordinator certification
• A minimum of three to five years’ experience in clinical research
• Previous ophthalmology experience

Responsibilities

• Serve as a subject matter expert on regulatory requirements and clinical trial best practices.
• Ensure timely submission of regulatory documents to study sponsors and regulatory agencies.
• Develop and maintain internal quality assurance processes to identify and correct potential compliance issues proactively.
• Serve as a resource during audits and regulatory inspections, and help facilitate FDA inspections alongside research leaders and study leads.
• Assist Vance Thompson Vision sites with submitting study start-up documents to sponsors, and coordinate site activation activities.
• Design, develop, and deliver effective training programs for new and existing research team members on topics such as regulatory compliance, documentation, and procedural updates.
• Establish and maintain communication channels to provide critical regulatory updates and changes to research team members.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed