Clinical Research Auditor

About the position Responsibilities • Conduct thorough audits of clinical trials to ensure compliance with federal regulations, GCP, and IND/IDE. • Work closely with various departments to ensure adherence to regulatory affairs and quality control standards. • Maintain detailed records of audits and prepare comprehensive reports. • Collaborate with research teams to provide guidance on compliance issues. • Stay updated on the latest regulations and best practices in clinical research. Requirements • 7 years of clinical research experience as a monitor/auditor, research nurse, research coordinator, regulatory affairs, quality control, and assurance or compliance. • Strong understanding of human subjects clinical research. • In-depth knowledge of federal regulations, GCP, and IND/IDE in both adult and pediatric research. • Proficiency in MS Word and Excel. • Excellent organizational and time management skills. • Ability to handle confidential and sensitive data with discretion. • Ability to multi-task, prioritize, and pivot in a fast-paced environment. Nice-to-haves • Strong understanding of medical records/patient charts organization and terminology. • Detail-oriented and resourceful with mature judgment. Benefits • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Apply tot his job Apply tot his job