Athena Felicie

At Fortrea, I lead start-up activation activities for clinical studies, building on more than a decade of experience at Labcorp and Covance.

I've helped deliver studies from start-up through database lock, serving as a primary contact for investigative sites and IRBs across activation, maintenance, and closeout. I manage CTMS, eTMF, and Trial Tracker workflows while maintaining accurate regulatory submission, correspondence, and approval records.

I review informed consent documents, support investigator-document approvals for timely drug shipment, and contribute to IND processes in line with FDA requirements. My work spans Phase I through IV studies, protocol and ICF amendments, feasibility alignment, site contracts, budgets, and FPI targets.

I bring an RN and biology background to regulatory oversight, risk-based monitoring, audit readiness, and collaboration with sponsors, CROs, investigators, vendors, and regulatory authorities. I also mentor project management team members and provide actionable insights to sponsors and leadership.