Clinical Research Internal Auditor

Overview

Conduct internal audits of clinical trials to ensure regulatory compliance

Key Responsibilities

• enrollment audits
• staff training
• data verification
• audit reporting
• ctms tracking
• protocol audits

Tasks

-Perform new employee enrollment audits focusing on GCP, IRB SOPs, and best practices. -Collaborate with the QAE Program Manager to onboard and train CTO staff on SOPs, IRB policies, GLPs, GCPs, and ICH guidelines. -Verify source documentation for selected CRF fields and confirm subject eligibility. -Prepare and submit audit reports using standard templates and document findings in the clinical trials management system (CTMS). -Track audits, sponsor monitor letters, and performance reports using OnCore CTMS, CTO Clinical Data Center, and NCI RAVE metrics. -Maintain expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations. -Conduct internal audits of national cooperative group trials, Phase II studies, and high-risk protocols to ensure protocol compliance.

Requirements

• oncology
• 2+ years
• bachelors
• fda
• gcp
• ich

What You Bring

-Oncology experience highly preferred. -2+ years’ experience as an within internal auditing/regulatory affairs for clinical trials. -Bachelors Degree or higher required. -Expert knowledge of FDA, GCP, ICH, IRB, and institutional regulations.

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Benefits

-Medical, dental & vision -Short and long-term disability -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Transportation benefits -Health Spending Account (HSA) -Time Off/Leave (PTO, Vacation or Sick Leave) -Employee Assistance Program -Critical Illness, Accident, and Hospital -Life Insurance (Voluntary Life & AD&D for the employee and dependents)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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