GCP Compliance Auditor - 2006210

Title: GCP Compliance Auditor

Location: Springfield, Massachusetts

Contract Details: The contractor would manage from 5 to 6 audits. Each audit should take the auditor a week.

Job Description:

• Conduct audits of clinical trials to ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company policies.
• Review study protocols, investigator brochures, informed consent forms, and other trial-related documents for accuracy and adherence to GCP standards.
• Perform on-site and remote audits of clinical trial sites, including monitoring activities, data management practices, and adherence to study protocols.
• Evaluate the quality and integrity of clinical trial data, ensuring proper documentation and reporting of adverse events and protocol deviations.
• Prepare audit reports detailing findings, observations, and recommendations for corrective and preventive actions (CAPAs) to address compliance issues.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to resolve audit findings and improve trial processes.
• Stay current with industry regulations, guidelines, and best practices related to GCP compliance and contribute to the development of training materials and programs for staff.

If you have specific qualifications or preferences in mind for this role, please let me know, and I can tailor the job description accordingly.