2267 Baker Avenue
Dallas, TX 75244
Job Objective Qualified GCP Auditor seeking work with an established firm in which to put my skills and knowledge to good use.
GCP Auditor, August 2005 – Present
Idexcel, Dallas, TX
- Planned and conducted external audits of clinical studies and third parties.
- Performed internal audits within the affiliate and at Country Offices in the affiliating territories.
- Provided advice and implemented compliance issues and the Quality Management System (QMS).
- Prepared and conducted audits and inspections.
- Ensured the safety, well-being and legal protection of subjects and the validity of study data.
- Ensured escalation of business critical compliance issues.
GCP Auditor, May 2000 – July 2005
Roche, Dallas, TX
- Performed assigned audits on internal GCP systems, external vendors and clinical sites.
- Utilized available information to provide well-informed audit findings and recommendations.
- Reviewed and verified GCP reports.
- Evaluated requirements of the protocol, informed consent form, case report forms, and essential documents.
- Assisted Inspection Management Team in regulatory authority inspections.
- Presented observations to appropriate representatives and prepared a written audit report.
Summary of Qualifications:
- Remarkable experience working in a clinical, regulatory and quality assurance environment
- Excellent knowledge of GCP auditing
- Good understanding of GCPs, ICH and procedures and practices in a clinical research setting
- Skilled in monitoring and auditing of EU and other non-US clinical trials
- Sound knowledge of FDA regulations, ICH guidelines, and corrective action plans, etc
- Sound ability to prioritize and understand work impact
- Ability to work under pressure and independently
- Excellent communication and intrapersonal skills
- Excellent report writing capabilities
Bachelor’s Degree in Physical, National American University, Rapid City, SD