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For your reference, we have included the original job posting below.
Good Clinical Practices (GCP) Auditor
Job Number:
43903211
Company Name:
Fladger Associates
Job Location:
Jacksonville, FL US
Job Category:
Accounting & Finance
Good Clinical Practices (GCP) Auditor
Review/assess clinical processes for compliance to federal regulations, International Conference for Harmonization (ICH) and Good Clinical Practices (GCP) guidelines, company SOPs and other relevant state or local regulations.
Partner with clinical operations and other clinical QA personnel to develop/enhance clinical processes and associated Sops where gaps exist.
Conduct and document GCP audit clinical investigational sites and Clinical Research Organizations (CRO’s).
Audit on-site Vision Care clinical investigational site.
Perform QC checks on clinical study reports, study data, etc.
Review general study documentation, including trial master files.
Provide general GCP SME support to clinical research teams.
Requirements:
Bachelor’s degree or equivalent experience required.
Five years of working experience in quality assurance, preferably in clinical quality assurance.
Five years of working experience in a clinical research setting with demonstrated proficiency in GCP. This experience can be combined with the quality assurance experience in the previous bullet
Auditing of clinical investigational sites and CROs experience preferred and a definite plus.
Experience with regulatory inspections preferred and a definite plus.
Demonstrated ability to partner with other internal functions and external service providers a plus.
