Job Details

Role: IRT Auditor
Location: Remote
Type: Contract
Length: 6 months

Position Summary:
We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of AI-driven technologies used in clinical trials. This role is essential to ensuring compliance across oncology programs that leverage artificial intelligence and machine learning (AI/ML) tools for clinical decision support, trial optimization, and real-world data interpretation.

Key Responsibilities:

• Plan, conduct, and report GCP audits across oncology clinical trials, vendors, and internal systems, with a focus on AI-enabled platforms and technologies.
• Evaluate the validation, data integrity, and compliance of AI/ML tools used in oncology studies according to GxP, FDA, EMA, and ICH guidelines.
• Perform risk assessments of AI technologies, including algorithm lifecycle oversight, data provenance, audit trails, and system interoperability.
• Collaborate with cross-functional teams to review AI model development and deployment strategies.
• Audit third-party vendors providing AI-powered platforms or services
• Provide subject matter expertise during regulatory inspections and serve as a liaison on AI-related compliance topics.
• Support CAPA development and track resolution of findings related to AI system audits and oncology trial quality issues.
• Maintain up-to-date knowledge of evolving AI regulatory landscapes (e.g., FDA AI/ML Action Plan, EU AI Act) and quality implications for oncology drug development.

Qualifications:

• Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or related field.
• Minimum 5 years of QA auditing experience in a GCP environment, preferably in oncology.
• Experience auditing clinical systems
• Familiarity with AI governance principles, including transparency, bias mitigation, algorithm validation, and traceability.
• In-depth knowledge of FDA, EMA, and ICH regulations related to clinical research and digital systems.
• Excellent communication, critical thinking, and cross-functional collaboration skills.
• Certifications such as RQAP-GCP or Certified Quality Auditor (CQA) are a plus.

Preferred Experience:

• Previous involvement in audits of decentralized or AI-supported trials
• Experience working in a biotech or mid-size pharma company with digital transformation initiatives.
• Understanding of data security, privacy (e.g., HIPAA, GDPR), and ethical AI use in clinical settings.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.