Grand Prairie, Texas, United States
Strategic Clinical Research Leader and Senior CRC with 8+ years of experience managing Phase I–IV trials across neurology, oncology, ophthalmology, internal medicine, women’s health, and medical devices. I excel at driving high-quality clinical research through site operations, monitoring, regulatory compliance, and eTMF/CTMS management under FDA, ICH-GCP, and ISO 14155 standards. I bring a strong blend of operational leadership and hands-on clinical expertise, including patient recruitment, phlebotomy, IV initiation, and lab specimen management. My experience spans decentralized and multi-site trials, leveraging AI-driven recruitment and digital platforms to optimize enrollment and enhance patient engagement. Known for building high-performing teams, mentoring staff, and streamlining workflows, I collaborate effectively with sponsors, CROs, and investigators to ensure audit-ready compliance, patient safety, and data integrity. Passionate about advancing clinical research innovation, I am eager to contribute my skills to organizations seeking strategic oversight, operational excellence, and patient-centered study management.
Coordinated clinical research activities across 15+ sites spanning medical devices, oncology, neurology, ophthalmology, internal medicine, women’s health, vaccines, and reproductive medicine, ensuring consistent protocol adherence. Managed patient screening, enrollment, follow-up, and retention to optimize study timelines and outcomes. Supported Principal Investigators and Sub-Investigators in maintaining compliance with FDA, ICH-GCP, and sponsor regulations. Maintained regulatory documentation, eTMF, and EDC systems to ensure audit-ready compliance. Prepared and coordinated on-site and virtual monitoring visits (SIV, IMV, COV), resolving 50+ site queries monthly. Partnered with Clinical Affairs and Data Management teams to streamline workflows, enhance data quality, and reduce query resolution time by 30%. Assisted with staff training, onboarding, and site support, fostering a culture of compliance and operational excellence. Acted as primary liaison between sites, sponsors, and CROs, representing IQVIA at investigator meetings, national conferences, and clinical operations discussions.
Coordinate clinical study activities remotely, including patient recruitment, scheduling, and virtual follow-ups. Ensure compliance with FDA regulations, company SOPs, and study protocols. Collect, review, and manage study data in electronic systems with accuracy and attention to detail. Support administrative tasks such as study correspondence, reporting, and workflow organization.
Neuroscience medical device's
Lead operations across multiple clinical research sites in California, Las Vegas, Dallas, and Lewisville, managing 300+ staff and 1,000+ patients. Oversee all phases of clinical research activities, including screening, enrollment, follow-up, and protocol adherence. Ensure compliance with FDA, ICH-GCP, and other regulatory guidelines, supporting Principal Investigators and Sub-Investigators. Maintain investigational drug/device accountability and storage, safeguarding patient safety and data integrity. Coordinate on-site and virtual monitoring visits, ensuring audit-ready documentation and regulatory compliance. Develop and maintain site files, regulatory binders, TMFs, informed consent forms, and study enrollment plans. Foster a patient-centric culture emphasizing quality, safety, and retention. Build and maintain strategic relationships with sponsors, CROs, investigators, and internal clinical/business teams. Represent the organization at national conferences, investigator meetings, and professional events.
Stage 2 , Stage 3 ophthalmology · Phase 2 - Ophthalmic · Conducting Protocol review · ICF conduct · Data entry & Query resolution · Investigational Product and Dispensation and accountability · Investigational product temperature control/ Excursion documentation · Regulatory (CTA, FDF, Training logs, DOA, CV, ML, CLIA, 1572, ) · Maintaining work relationships with CRO / Sponsor · QC check