Nicole Montilla

Managed Phase II (BARDA), Phase III double-blind (BI), and decentralized (ES) trials autonomously in a startup environment, overseeing both clinical and regulatory lifecycles without onsite supervision. Led all IRB submissions and regulatory workflows ensuring 100% audit-readiness and TMF compliance. Optimized data integrity and site infrastructure through CRIO, Curebase, and UAT for decentralized platforms, serving as the technical SME for eSource and tracking.

Clinical Research Coordinator at Walgreens. Co - Transformative Pharmaceutical Solutions (2025-11 – Present)

• Managed Phase II (BARDA), Phase III double-blind (BI), and decentralized (ES) trials autonomously in a startup environment, overseeing both clinical and regulatory lifecycles without onsite supervision.
• Led all IRB submissions and regulatory workflows ensuring 100% audit-readiness and TMF compliance.
• Optimized data integrity and site infrastructure through CRIO, Curebase, and UAT for decentralized platforms, serving as the technical SME for eSource and tracking.
• Accelerated site scaling and patient recruitment through aggressive cold-calling, public outreach, and internal QC audits to maintain inspection readiness

Clinical Research Coordinator at Columbia University Irving Medical Center (2024-12 – 2025-11)

• Coordinated Phase II–V trials across high-complexity indications, including CRISPR gene editing, PET radioactivity tracers, specialized medication, heart failure and physical therapy protocols while maintaining strict GCP/FDA compliance and inspection readiness.
• Lead ACT-Early phase IV study which required c-MRI, PYP, SPECT-CT, and SPECT.
• Served as Data Coordinator for C-Amyloidosis database, ensuring rigorous data integrity, protocol adherence, and precise source documentation all for presentations/future studies proposals.

Patient Care Associate at Mount Sinai West Hospital (2021-12 – 2024-04)

• Worked with immobile patients to prevent skin pressure wounds and provided wound care.
• Display strong clinical skills in assessing glucose checks, vital signs, post-mortem care, wound, phlebotomy, EKG and post-operative care for nursing/physician support.

Student at New York I-Corps Hub at The City College of New York (2024-12 – 2024-08)

• Conducted 275 interviews with CROs, medical providers, potential subjects, and industry experts across five teams, generating insights that guided the development of our endoscopic surgical device for GERD under the principal investigator Steven B. Nicoll of the company Cellulora

Bachelors of Science in Biology – The City College of New York (2023)

Masters of Science in Translational Medicine – The City College of New York (2024)