The incumbent is responsible for managing and conducting investigator site GCP audits; and providing GCP training internally and externally. We are looking for a highly driven individual who will thrive in a results-oriented, fast-paced environment. The incumbent will perform the qualification or requalification of clinical Contract Research (CRO) service providers as directed. The incumbent will be responsible for assuring those suppliers/contractor/service providers associated with Contract Research activities are operating in compliance to GCPs, pertinent regulations and established industry standards. The incumbent will coordinate and perform external audits of Contract Research Organizations and other vendors/suppliers or assigned. The incumbent will assist in evaluations of quality systems employed by a supplier/contractor and when directed assist supplier/contractors in improvements. The incumbent will issue detailed written audit reports for vendor and investigatory site audits and will track and review all audit responses for complete corrective and preventative actions. The incumbent will contribute to the preparation and revision of standard operating procedures related to research and development, will conduct Investigator Site GCP Audits for selected clinical studies and investigator sites to assure Clinical Research Investigators are operating in conformance to GCPs, FDA regulations, ICH Guidelines and established standards.
Qualifications include Bachelor’s Degree in a scientific discipline, at least 7 years of experience in a regulated pharmaceutical environment, a minimum of 5 years of GPC auditing or clinical research monitoring experience, a comprehensive understanding of GCP, GMP and GLP FDA and ICH regulations. Strong interpersonal, teamwork, organizational and workload planning skills are required, along with the ability to travel up to 25%.
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