Auditor, Clinical Trials Audit - Health Affairs - Emory University

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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.

 

JOB DESCRIPTION:

• 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.

NOTE: 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 upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee.

Emory Supports a Diverse and Inclusive Culture:

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. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.
Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.