Sr. Clinical QA/Auditor Specialist In this position the incumbent shall independently conduct a series of detailed GCP audits of Phase I – III domestic and international clinical research trials and/or GCP-related systems and processes to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, study reports, and GCP-related systems/processes for clinical trials. Essential Functions Plans, schedules, and conducts QA audits to assure adherence to company Standard Operating Procedures, and any applicable regulatory requirements. Audits clinical investigator, trial master files, system/process, document and vendor audits/assessments. Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved. Recommends corrective action to compliance issues and/or observations as needed to insure corrective action is implemented. Monitors clinical operations corrective action process to insure corrective actions are being applied Works with supervisor to develop and maintain standard operating procedures. Provides support to management during regulatory sponsor monitor inspections, as needed. Other projects and responsibilities may be added at the company's discretion. Job requirements and qualifications: BA/BS degree in biological sciences, nursing or related discipline, or equivalent experience required Strong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is required Experience in QA audits of Clinical Investigators Experience in QA audits of Clinical documents associated with clinical trials Experience in system/process audits Experience in development of SOPs Working knowledge and understanding of drug development and global clinical regulatory environment Ability to manage multiple projects Effective organizational skills Effective team player and detail oriented Strong attention to detail, good organizational skills, ability to work independently Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel Knowledge Requirements: Knowledge of the code of federal regulations, European Directives, ICH/GCP practices and clinical auditing processes experience. Experience: A minimum of 3-5 years working experience as a clinical quality assurance auditor. Travel is required, 25-35%, physical requirements, on-call schedules, and etc. Please refer to job code 4330-JM when responding to this ad. Location: Exton, PA Compensation: Open OK to highlight this job opening for persons with disabilities Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests. delaware