Job Description

Role Overview:

The audit management specialist is responsible for managing the audit program, pre-audit planning, leading the audit, and following up internally and externally to get findings efficiently and effectively resolved. The range of audits in scope include but are not limited to sponsor audits and regulatory inspections directly impacting CTNx. The audit management specialist will also conduct internal audits and compose summary audit reports and effectively communicate the findings and observations to CTNx leadership.

Key Accountabilities:

• Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity.
• Maintain an audit and inspection program to support GCP regulatory inspections.
• Perform audits of CTNx systems and processes to ensure adherence to standards and requirements.
• Define, refine, and manage our audit processes and procedures to ensure they continue to represent best practice in our industry. Maintain an in-depth knowledge of regulations impacting clinical research.
• Prepare fully for upcoming audits and inspections to ensure all possible documentation, subject matter expertise, systems and other forms are evidence are fully available and in best order.
• Conduct and host audits with a positive and professional demeanor and ensure best current audit practices are employed.
• Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures. Escalate significant findings to CTNx Management.
• Work with study teams to formulate Corrective and Preventive Action Plans (CAPAs) based on audit findings, deviations, and events; conduct follow up audits to assess if the desired effect/change was achieved.
• Use the quality assurance process as an opportunity for continuing education of study teams.
• Track assigned research projects utilizing a risk-based assessment tool to prioritize research studies for in-depth review.

Knowledge, Skills & Attributes:

• Previous knowledge and experience in audit and inspection management, and management of audit programs.
• Minimum 3 years of relevant audit experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.
• Comprehensive knowledge of the clinical trials process in addition to specific understanding of relevant regulations and guidelines including 21CFR-Part11 and ICH-GCP.
• Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions.
• Solid computer literacy, interpersonal skills, and ability to function independently within an environment that relies on technology for information and communication.
• Knowledge of governmental regulations impacting clinical research.
• Flexible, resourceful, and adaptable to rapidly changing environment with competing priorities.
• Able to develop effective working relationships with site staff and colleagues.
• Knowledge of Electronic Data Capture Systems such as Medidata RAVE.
• Domestic Travel up to 50% (Ability to travel as needed to support audits and inspections)

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

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