Clinical Research Auditor

$79,040 - $87,360/Yr

Actalent - Philadelphia, PA

Full-time - Mid Level

Hybrid - Philadelphia, PA

10,001+ employees

Administrative and Support Services

About the position

The Clinical Research Auditor is responsible for conducting thorough audits of clinical trials to ensure compliance with federal regulations and Good Clinical Practice (GCP). This role involves collaboration with various departments to maintain quality control standards and provide guidance on compliance issues, while staying updated on the latest regulations in clinical research.

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)