Marcey Jiles

At Duke Clinical Research Institute, I monitor 15 Phase III trial sites, completing source data verification, query management, data integrity assessments, and regulatory reviews to keep trial data inspection-ready. I've facilitated 20 site initiation visits, 70 monitoring visits, and 25 close-out visits while reconciling investigational product accountability and essential documentation.

My work spans clinical monitoring, quality assurance, regulatory oversight, and research engagement. I use CAPA, InForm, Veeva Vault, CTMS, RAVE, and REDCap to review informed consent forms, FDA Form 1572s, delegation logs, and trial records against ICH-GCP, protocol, and SOP requirements.

I've also served as a voting IRB member, trained faculty investigators in human subjects research, managed engagement portfolios, and mentored research staff and students. I'm pursuing a Quality Assurance Manager role where I can lead GCP compliance, audit readiness, and quality systems across clinical trial operations.