The purpose of this position is to manage and lead GCP Audits to assure that all aspects of clinical studies conducted have been executed in compliance with applicable US FDA, ICH GCP Guidelines and other government and/or country specific regulations. Also, this manager will lead the identification of internal GCP quality issues. They will be a catalyst for process improvements, and partner with Clinical Operations and Clinical Development functional groups to promote standardization and best practices. Job Specs and Requirements: * Plan, conduct and report audits of clinical investigator sites, vendors, clinical study reports, trial master files and other clinical documents (e.g. CTD sections) * Maintenance of appropriate GCP audit documentation * Follow up on audit findings and corrective actions to closure * Identification of compliance issues through the use of internal and external audit programs to minimize regulatory and business risk * Assure the integrity and quality of clinical data by independently manage, lead, participate, and follow-up on routine and directed; internal and external; domestic and international GCP audits. Audits include, but are not limited to: investigator study sites, vendors, study reports, and internal systems. * Review audit reports to provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans. * Provide quality reviews of protocols, amendments, and other study specific documents as requested for consistency and acceptable standards and practices to ensure Clinical Operations and Clinical Development is in compliance with internal standards, US FDA regulations and ICH GCP guidelines. * Travel, as required, up to approximately 25% of the time * At least 4-6 years Clinical QA experience, including internal/external GCP audits, is required * Demonstrate a thorough knowledge of GCP regulations and guidelines * Excellent written, oral and interpersonal skills If you are interested in learning more and being submitted for an interview, please respond with contact information to b.ross(@)realstaffing.com. If you know of anyone who may be a good fit, please forward on the opportunity. Thank you for your interest!
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