Clinical Quality & Compliance Specialist

AAIPharma is a leading international provider of pharmaceutical and biotechnology product development services. Our employees work in state-of-the-art facilities using leading edge technologies to meet exciting drug development challenges. We are seeking candidates for the following position located in Morrisville, NC:   Clinical Quality & Compliance Specialist   Responsibilities include hands-on quality oversight during Phase I studies, review of study documentation and monitoring activities through audits to assure that operations are conducted according to local regulations and Good Clinical Practices (GCPs) as defined by FDA regulations and guidelines, ICH, company Standard Operating Procedures (SOPs) and client protocols; review of final study reports; tracking of clinic quality performance; participation on project teams and client and regulatory agency audits; providing compliance guidance to external and internal clients; develop and deliver training to clinic staff regarding clinical research and regulatory compliance.    Qualifications include a BS degree in a scientific-related field plus at least six years of experience in the pharmaceutical/biotech industry or research community in a Clinical Quality Assurance role. Experience in a Phase I clinic setting is a plus. Experience mainly in the areas of GMP or GLP does not qualify. Additionally, the successful candidate will:   ·  Have a strong understanding of the Phase I study process, Clinical Quality Assurance, local, State, and Federal regulations, GCPs, and the regulations and guidelines regarding Phase I clinical trials; · Understand CRO business processes and client relationships; · Be able to effectively communicate with staff, clients and members of the health care community including physicians, nurses and pharmacists; and  · Work at a high level of quality with superior attention to detail.   We offer competitive salary, a comprehensive benefits package and advancement opportunity.    AAIPharma is an Equal Opportunity/Affirmative Action Employer M/F/D/V

Job Code : Clinqual808 Travel Required : None