Danielle Downer

About Danielle Downer

Master’s-level Clinical Research Professional with 3 years of experience coordinating Phase I–IV clinical trials, with a strong foundation in regulatory documentation, protocol compliance, and patient-centered research operations. Currently supporting multi-sponsor ophthalmology studies with a focus on audit readiness, subject protections, and cross-functional coordination. Passionate about the intersection of science, ethics, and operational excellence in clinical research—and committed to continuous learning and professional development across both site and sponsor-facing environments. Open to collaboration, mentorship, and knowledge-sharing in clinical trial operations, compliance, and research integrity.

Experience

1. Clinical Research Coordinator

   PRISM Vision Group

   Sep 2022 — Present · Chevy Chase, MD, US

   Lead recruitment efforts in screening potential patients while focusing on retention in active studies• Obtain and document informed consent as approved by the IRB and greenlit by the sponsor• Create CRFs by inputting study data into electronic data capture systems• Manage and ensure completion of study activities per protocol for >15 Genentech/ Roche, Janssen, Kodiak, and Iveric Bio ophthalmic clinical trials• Maintain compliance with GCP, 21 CFR, ICH, and IATA guidelines

Education

• Drexel University

  Master's degree

  2020 — 2022

• Towson University

  Bachelor's degree

  2013 — 2017

Skills

• Communication
• Cardiopulmonary Resuscitation (Cpr)
• Time Management
• Teamwork
• Microsoft Excel
• Leadership