Quality Auditor

Job Category: Quality Assurance/Safety Career Level: Experienced (Non-Manager) Location: Culver City, CA 90323           Job Description: Since 1983 California Clinical Trials (CCT) has been at the forefront of drug development. Our best-in-class clinical experts, research staff, and trained physicians all work together seamlessly to bring hope to patients around the world. Our executive team comprises outstanding leaders in medical science. Whether you need careful patient selection for your Phase 1 studies, or experience in drug development and research for Phase II-IV operations, CCT quality and performance allow you to make 'go/no-go' decisions about your products. With our help, you get your products to market, fast. In 2003 CCT moved its Early Drug Development unit into a wing at Glendale Adventist Medical Center in Glendale, California. This makes us the only hospital-based Phase I Unit in Southern California. And CCT guarantees consistency of procedures and superior performance across all of our locations. Our clinical investigative sites in Glendale, Los Angeles, Culver City, and San Diego, as well as our two sleep centers make a powerhouse single-source solution for your clinical trial needs. Additionally, with the purchase of CCT by Parexel, there will be an expansion of sleep beds to further demonstrate our dominance. As part of the Quality Management Department, the Quality Auditor systematically monitors and evaluates various aspects of CCT's projects and research sites to ensure that standards of quality are being met. The Quality Auditor's main function is to ensure compliance with FDA Regulations, ICH/GCP Guidelines, Study Protocols, Clinical Operating Guidelines (COGs), Department Training Manuals, Quality Management Training Manual, and Industry Standards/Practices. The Quality Auditor is integral to the preparation for regulatory inspections and the preparation and/or hosting of sponsor audits. This position reports to the Director, Quality Management and Regulatory Affairs.Major Responsibilities' Provides advice and recommendations to the clinical departments regarding protocol interpretation/guidance and application of good clinical practice guidelines, Clinical Operating Guidelines, Clinical Training guidelines, and industry guidelines.' As established by the Quality Management Department Plan, executes duties pertaining to o Quality Control Involved in the review of source data. Involved in the review and finalization of source documentation intended to capture source data at assigned sites.o System evaluations and audits  Performs audits of pharmacy/drug room and laboratories. Performs observation of select dosing and blood draws.o Preparation and/or hosting of sponsor audits.o Training (e.g. Identification of training needs, providing training sessions, etc.)o Performing special investigations as assigned by senior management. o Attending relevant staff/clinic meetings and trainings. o Generates audit reports of findings and communicates these findings to the appropriate Department/Senior Manager(s) and the Director, Quality Management and Regulatory Affairs.o Assists in preparation of (in conjunction with the Director, Quality Management and Regulatory Affairs and Research Regulatory Compliance) inspections initiated by the FDA at assigned site locations. o Leads preparation (in conjunction with the Clinical Department Manager[s]) of audits initiated by a Sponsor company or Contract Research Organization (CRO). Acting host of such audits.' Development, maintenance, and training of the Quality Management Department Training Manual.' Involved in the development and training of the Clinical Training Manual, as appropriate.' Maintains and updates knowledge of Clinical Operating Guidelines, Clinical Training Manual, and Quality Management Department Training Manual and their proper application.' All other duties as assigned. Qualifications:RN, LVN, BSN, BS or BA in a related field.1-2 years clinical research experience preferred.Computer literacy.Travel required.Flexible schedule.Skills:Good judgment skills and autonomous decision making skills.Meticulous attention to detail.Adequate technical vocabulary.This position requires strong interpersonal, written/verbal communication and organizational skills.Must have the ability to effectively manage time, manage resources, and multi-task. RN, LVN, BSN, BS or BA in a related field.1-2 years clinical research experience preferred.Computer literacy.Travel required.Flexible schedule. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2195609&boardid=749