Gary Nelson

About Gary Nelson

Clinical research professional with experience supporting Phase oncology clinical trials across the full study lifecycle, including study startup, monitoring visits, and trial closeout. Skilled in regulatory compliance, essential study documentation, and facilitating communication between sponsors, investigators, and cross-functional clinical research teams. Experienced in working within ICH-GCP and FDA regulatory frameworks while supporting efficient trial operations and maintaining inspection-ready study documentation throughout the clinical trial lifecycle.

Experience

1. Regulatory Assistant

   UNC Lineberger Comprehensive Cancer Center

   Dec 2022 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Support regulatory and operational execution of multiple Phase oncology clinical trials by coordinating essential documentation, facilitating sponsor communication, and ensuring regulatory compliance throughout the clinical trial lifecycle.• Coordinate study startup and closeout activities, ensuring essential documents are collected, verified, and maintained in accordance with ICH-GCP and sponsor requirements.• Serve as a primary liaison between study sponsors, investigators, regulatory teams, and clinical staff, facilitating communication during study startup, monitoring visits, and trial lifecycle milestones.• Support monitoring visits and audit preparation by organizing regulatory documentation, responding to monitor inquiries, and coordinating resolution of findings and action items.• Manage regulatory documentation across multiple active clinical trials, including IRB submissions, protocol amendments, continuing reviews, and study closures.• Maintain trial master regulatory files and essential documents, ensuring accuracy, completeness, and inspection readiness for sponsor and regulatory review.• Collaborate with cross-functional study teams to track trial milestones, address regulatory inquiries, and ensure timely completion of startup and lifecycle deliverables.• Review oncology patient clinical records and protocol criteria to support accurate trial documentation and eligibility verification.

Education

• Winston-Salem State University

  Bachelor of Business Administration - BBA, Business Administration and Management, General

  2017 — 2020

• Tennessee State University

  Master of Business Administration - MBA, Business Administration and Management, General

  2021

• Trevecca Nazarene University

  Doctor of Business Administration, Business Administration and Educational Leadership