Clinical Trials Auditor

1 day ago

Atlanta, Georgia, United States Emory HealthcareEmory University Full time
Job Summary

Emory University is seeking a highly skilled Clinical Trials Auditor to join our team. As a Clinical Trials Auditor, you will be responsible for ensuring compliance with federal and state laws and regulations, as well as the University's policies and procedures related to clinical trials.

Key Responsibilities
  • Conduct audits to ensure compliance with study or sponsor SOPs, GCP, and expectations for data accuracy and completeness.
  • Develop, execute, and maintain audit schedules according to project needs.
  • Track, collect, and report audit findings in writing and in-person to the study team.
  • Identify root causes of noncompliance and provide corrective and preventative action plans.
  • Provide timely feedback through audit reports and ensure timely completion of all audit-related activities.
  • Perform CAPA audits and educate study teams on GCP and Emory clinical trial requirements.
  • Participate in project training on the audit process and assist as a coach/mentor for less-experienced auditors.
  • Interpret regulations and guidance documents governing GCP and apply them to daily work according to the audit plan and client representatives.
  • Ensure that all human subject or clinical trial audit reports are accurate and of the highest professional quality.
  • Assist the Director in risk assessments and prepare office-related work plans and reports.
  • Participate in the selection of protocols based on risk matrix and evaluate potential risk of compliance deficiencies.
  • Assist in preparing for external audits by regulatory agencies or customers.
  • Develop reports for management as requested.
  • Provide assistance and information to the Director.
  • Review corrective action plans/audit responses for adequacy.
  • Assist with the creation of quality/compliance training programs and deliver training programs with research administrative departments.
  • May hire, manage, or supervise other employees.
Requirements
  • A bachelor's degree in a biomedical science or related field and three years of monitoring/auditing experience (preferably in GCP) or an equivalent combination of education, training, and experience.
  • Technical knowledge applicable to clinical trials required.
  • Experience in clinical research organization preferred.
Work Environment

This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based on business needs. Schedule is based on agreed-upon guidelines of the department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to the employee.

Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status.

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