Clinical Quality and Regulatory Lead
Topography HealthMaryland, United States • Colorado, United States • Michigan, United States • Wisconsin, United States • Washington, District of Columbia, United States • Washington, District of Columbia, United States
Posted September 16, 2025
Full Time
About the Company
Topography Health empowers physicians by building tools and services to overcome barriers in research. Our mission is to increase the number of physician-investigators by 10x and expand patient access similarly, believing that every physician can contribute to research.
Job Description
This position is seeking a Clinical Quality and Regulatory Lead to support the clinical team in ensuring high-quality trials. The role involves regulatory compliance, quality assurance, study site management, regulatory document preparation, audit support, and training. The ideal candidate will be detail-oriented, proactive, and have a strong understanding of clinical research best practices.
Requirements
- Prepare, submit, and manage regulatory documents.
- Serve as the main point of contact for central and local IRBs.
- Support monitoring visits and sponsor inspections.
- Conduct, initiation, monitoring, and close-out visits remotely.
- Conduct quality control checks and data reviews.
- Develop and execute CQMPs.
- Facilitate audits and inspections.
