Research Quality Assurance and Compliance Supervisor

Job Opportunity

We are growing and we are looking for a Research and Regulatory Compliance Specialist to join our team!

About the role

You Are Ready to live out our core values in patient and team member interactions
Detail-oriented, and a critical thinker
A clear communicator, and able to collaborate with others
An independent learner who has the ability to problem solve

Responsibilities

• Supervising and leading the research coordinator team, overseeing their day-to-day clinical study workflows and patient-facing activities to ensure operational excellence.
• Serving as a subject matter expert on regulatory requirements and clinical trial best practices. Ensuring timely submission of regulatory documents to study sponsors and regulatory agencies.
• Developing and maintaining internal quality assurance processes to identify and correct potential compliance issues proactively. Serving as a resource during audits and regulatory inspections, and helping facilitate FDA inspections alongside research leaders and study leads.
• Assisting Vance Thompson Vision sites with submitting study start-up documents to sponsors, and coordinating site activation activities.
• Designing, developing, and delivering effective training programs for new and existing research team members on topics such as regulatory compliance, documentation, and procedural updates.
• Establishing and maintaining communication channels to provide critical regulatory updates and changes to research team members.

Requirements

• One to two years of leadership, supervisory, or team lead experience.
• A Clinical Research Coordinator certification.
• A minimum of three to five years’ experience in clinical research.
• Previous ophthalmology experience.

Qualifications

• Exceptional attention to detail.
• Strong problem-solving skills.
• Excellent communication and collaboration abilities.
• Ability to learn quickly and adapt to new information.

Skills

• Regulatory compliance knowledge.
• Effective communication and collaboration skills.
• Problem-solving and critical thinking skills.
• Training and development experience.

Benefits

Vance Thompson Vision is an equal opportunity and affirmative action employer. We are committed to creating a diverse and inclusive culture for all employees.

Pay

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Schedule

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Benefits

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