Home » Job Descriptions » Auditor, Clinical Trials Audit

     
Pay Range Minimum
Job Code:
 SF21
Hourly:
 $33.17
FLSA*:
 Exempt
Monthly:
 $5,750
Grade:
 235
Annually:
 $69,000

*This is an Exempt position. Employees in this position are paid a salary on a monthly basis and are not eligible to receive overtime pay.
JOB DESCRIPTION: Performs audits of clinical trials to ensure compliance with federal and state laws and regulations and the University's policies and procedures relating to conduct and practices within Clinical Trials. Conducts audits to assure compliance with study or sponsor SOPs, GCP, and expectations for data accuracy and completeness. Develops, executes and maintains audit schedules according to the needs of the project. Tracks, collects and reports audit findings in writing and in-person to the study team. When noncompliance is found, the auditor works with the study team to identify root causes and provides corrective and preventative action plans. Provides timely feedback by means of the audit report and ensures timely completion of all audit related activities. Performs CAPA audits. Educates study teams on GCP and Emory clinical trial requirements. Participates in project training on the audit process, as well as assisting as a coach/mentor in the development of less-experienced auditors. Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work per the audit plan and client representatives. Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional quality. Assists the Director in risk assessments and the preparation of any office-related work plans and/or reports. Participates in selection of protocols based on risk matrix. Evaluates the potential risk of compliance deficiencies. Assists in the preparation for external audits by regulatory agencies or customers. Develops reports for management as requested. Provides assistance and information to the Director. Reviews corrective action plans/audit responses for adequacy. Assists with the creation of quality/compliance training programs and assists with the delivery of training programs with research administrative departments. May hire, manage, or supervise other employees. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: 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 that is applicable to clinical trials required. Experience in clinical research organization preferred.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

EQUAL EMPLOYMENT OPPORTUNITY / AFFIRMATIVE ACTION EMPLOYER:

Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law.
Click here to return