Jesse Molina Melo

About Jesse Molina Melo

Clinical research professional with four years of experience supporting Phase trials within high-volume academic oncology environments. Experienced across the full study lifecycle, including feasibility assessments, site selection visits, study start-up, routine monitoring, and close-out.Collaborated in 43 monitoring visits and 3 close-out visits, reviewing monitoring follow-up letters, driving structured corrective action discussions, and responding to sponsor-identified findings to maintain continuous inspection readiness. Contributed to 13 site feasibility assessments and supported 9 site initiations through regulatory coordination and operational readiness planning.Skilled in SAE documentation review, investigational product verification support, deviation trending, and risk mitigation across concurrent oncology protocols. Familiar with sponsor systems including Medidata RAVE, Veeva, OnCore, ICON FireCrest, and other sponsor CTMS platfotms.Actively pursuing entry-level and bridge Clinical Research Associate pathways where site-level monitoring collaboration experience can translate into independent oversight within a CRO or sponsor environment.Eligible to travel up to 50% for regional monitoring responsibilities.

Experience

1. Clinical Research Coordinator (Oncology)

   Rush University Medical Center

   Mar 2023 — Present · Rush Cancer Center, IL

   Supported full trial lifecycle activities across 54 Phase oncology protocols within a high-volume academic cancer center, integrating start-up coordination, monitoring collaboration, and corrective action planning to maintain inspection readiness.• Contributed to 13 site feasibility assessments evaluating enrollment projections, competing studies, and operational capacity to inform sponsor site-selection decisions• Coordinated and participated in site selection visits, aligning cross-functional stakeholders and facilitating sponsor evaluation of site capabilities• Supported activation of 8 oncology trials through IRB submissions and protocol-driven budget questionnaires, enabling on-time initiation across 9 SIVs• Collaborated during 43 monitoring visits (remote and on-site), preparing source documentation for SDV/SDR review and resolving 97–98% of queries pre-visit• Reviewed monitoring follow-up letters and led internal action planning to address sponsor findings and prevent recurrence• Responded directly to monitoring action items by reconciling documentation discrepancies and coordinating corrective measures• Participated in 3 site close-out visits, reconciling subject data and documentation prior to archival• Reviewed SAE documentation for protocol adherence and reporting compliance• Documented and trended 38 protocol deviations, facilitating corrective discussions that reduced recurrence across active protocols

Education

• University of Illinois Urbana-Champaign

  B.S., Biochemical Neuroscience

  2015 — 2020

• The CRA Academy

  Clinical Research Associate Certification (Clinical Monitoring), Clinical Research

• Rush University

  M.S., Biotechnology

  2020 — 2021