The Clinical Trial Monitor 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. Each Compliance Monitor will maintain a set of sites and help train newly onboarded coordinators according to CTNx Coordinator Training Program.

Key Accountabilities:

• Conduct SOP/GCP/Compliance Training with coordinators at site.
• Ensure sites are adhering to CTNx’ s policies and procedures.
• 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.
• Complete internal audits based on audit schedule provided by Compliance Manager.
• Work with sites to report protocol deviations for all studies.
• 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.
• Coach and Support CRCs and PIs on a continuous basis based upon audit findings.
• 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 1 year 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.
• Domestic Travel up to 40% (Ability to travel as needed to support audits and inspections)

Job Type: Full-time

Salary: $55,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8-hour shift
• Day shift
• Monday to Friday

Education: Bachelor's (Required)

Experience: Clinical Trial Auditing: 1 year (Preferred)

Willingness to travel: 40% (Preferred)

Work Location: One location

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person