Luke Allen

Experience

1. Senior Clinical Research Associate

   On Target

   Apr 2026 — Present

   Develop strong site relationships and ensure continuity of site relationships through all phases of the trial-Perform clinical study site monitoring activities in compliance with ICH-GCP, company SOPs, Local Laws & Regulations, Protocol, Study Monitoring Plan and associated documents-Perform remote and on-site monitoring and oversight activities to ensure that data generated at the sites are complete, accurate, and unbiased and that subjects’ rights, safety, and well-being are protected-Conduct site visits including but not limited to evaluation visits, initiation visits, interim monitoring visits, close-out visits-Produce clear and accurate monitoring of visits reports and visit correspondence-Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out-Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance-Identify, assess, and resolve site performance, quality or compliance problems and escalate as appropriate to leadership-Assist with development of study-related documents such as study monitoring plans, informed consent forms, source documents, and/or case report forms-Manage and maintain information and documentation in CTMS, eTMF, and/or various other systems as appropriate and per timelines-Support audit/inspection activities as needed-Manage, monitor, and communicate Investigator Sponsored Study activity to ensure adherence to established timeline

Education

• James Madison University

  Bachelor of Science - BS, Public Health Education

  2017 — 2019

• Blue Ridge Community College (Virginia)

  Associate's degree, General Education

  2015 — 2017