Samantha B

Experienced Clinical Research Professional with 15+ years of experience supporting Phase I–IV clinical trials in oncology, pulmonology, urology, maternal health, neurology, medical devices, and pharmaceuticals. Strong background in clinical monitoring, regulatory compliance, GCP/ICH guidelines, site management, internal auditing, investigator support, biospecimen management, and clinical operations. Experienced collaborating with sponsors, CROs, investigators, IRBs, and multidisciplinary research teams to ensure protocol compliance, patient safety, and data integrity.

Trilingual in English, Spanish, and Portuguese.

Clinical Research Associate Consultant & Director at Nopal Research Professionals, LLC (2024-06 – Present)

• Conduct internal clinical research audits and monitoring activities for research sites preparing for FDA inspections and sponsor audits
• Review SOPs, regulatory documentation, informed consent processes, and protocol compliance
• Evaluate site readiness, identify compliance gaps, and provide CAPA recommendations
• Support site initiation, maintenance monitoring, and close-out activities
• Verify safety reporting procedures, investigational product storage, and research documentation accuracy
• Train and mentor research staff on GCP, regulatory compliance, and clinical operations
• Prepare audit reports, monitoring documentation, and operational improvement plans
• Collaborate with site leadership, HR, investigators, and coordinators to improve research infrastructure and compliance

Clinical Research Coordinator Department Manager at Arizona Blood & Cancer Specialists / OneOncology (2025-01 – 2026-04)

• Assisted in development and implementation of a clinical trials unit focused on oncology and hematology research
• Coordinated clinical trial operations under Principal Investigator oversight
• Maintained regulatory documentation and ensured protocol compliance and patient safety
• Supported investigator training for PI/Sub-I responsibilities and clinical trial processes
• Collaborated with sponsors, CROs, and internal departments on study activation and management
• Assisted with budgeting, coverage analysis, billing compliance, and workflow optimization
• Participated in OneOncology/OneR Quality Committee initiatives

Clinical Research Coordinator II & ALA National CRC Representative at Asthma & Airway Disease Research Center (A2DRC) – University of Arizona (2023-05 – 2024-05)

• Coordinated pulmonary and respiratory clinical trials for the American Lung Association
• Managed regulatory submissions, informed consent reviews, and audit readiness activities
• Collected and processed biospecimens including phlebotomy, sputum induction, nasal swabs, and pulmonary testing
• Collaborated with investigators on asthma, allergy, cystic fibrosis, and pulmonary device studies
• Ensured protocol adherence, source documentation accuracy, and data quality
• Served as National Clinical Research Coordinator Representative for the American Lung Association
• Presented coordinator challenges and operational recommendations to executive leadership

Senior Clinical Research Coordinator III at University of Arizona – Department of Surgery (2022-06 – 2023-02)

• Supported clinical research operations for vascular and cognitive impairment studies
• Managed regulatory compliance, study documentation, and sponsor audit preparation
• Assisted with CRF development, study tools, onboarding, and research staff training
• Conducted protocol-specific assessments including ABI, TCD, MRI coordination, and neurocognitive testing
• Provided guidance regarding corrective actions and research compliance processes

Clinical Research Coordinator at Arizona Urological Specialists / Urological Associates of Southern Arizona (2020-12 – 2022-05)

• Coordinated sponsor-funded urology and oncology clinical trials involving bladder cancer, BPH, OAB, and prostate studies
• Managed subject screening, informed consent, EDC entry, IVRS enrollment, and investigational product accountability
• Performed laboratory procedures including phlebotomy, EKGs, specimen processing, storage, and shipment
• Collaborated with sponsors and monitors during site visits and query resolution
• Maintained IRB submissions and regulatory documentation

Clinical Research Coordinator at Watching Over Mothers & Babies (WOMB) (2019-01 – 2020-11)

• Coordinated maternal and infant vaccine safety clinical trials
• Conducted study visits, patient recruitment, regulatory maintenance, and sponsor communications
• Supported monitoring visits, site initiation activities, and close-out processes
• Maintained study databases, subject tracking, and reporting documentation
• Assisted with contracts, budgets, and payment reconciliation

Research Specialist / Clinical Research Coordinator at University of Arizona Cancer Center (2014-12 – 2015-04)

• Supported breast and gynecologic oncology clinical trials
• Assisted with sponsor EDC systems, IVRS enrollment, patient follow-up, and monitoring visits
• Coordinated regulatory submissions and managed multiple studies from startup through archival
• Participated in industry-sponsored, cooperative group, and investigator-initiated trials

Clinical Research Associate & Auditor at Research Technology Management (RTM), LLC (2002-04 – 2010-01)

• Conducted internal monitoring, QA/QC audits, and regulatory reviews for pharmaceutical and medical device clinical trials
• Ensured compliance with FDA regulations, ICH-GCP guidelines, and IRB requirements
• Assisted with sponsor audits and FDA inspections
• Trained research staff on SOPs, compliance procedures, and clinical trial operations
• Assessed research processes and identified compliance risks and corrective actions
• Prepared monitoring and audit reports and maintained regulatory documentation

Associate of Science in Clinical Research – Pima Community College (2012 – 2013)

Bachelor of Arts in Interdisciplinary Studies – University of Arizona (2008 – 2010)

Associate of Arts in Spanish – Pima Community College & ITSON (2005 – 2008)