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QA Auditor

Company: Jobot
Location: Garden Grove
Posted on: August 4, 2022

Job Description:

A bit about us:Be part of one of the largest and fastest-growing clinical research companies in the United States with potential internal growth and advancement.Work alongside a successful and dynamic team conducting clinical trials for new medications and treatment in various therapeutic areas not limited to psychiatric, general health, and neurological phase I-IV studies.Why join us?Great benefits and perks.Job DetailsJOB SUMMARYThe Sr. QA Auditor will initiate and conduct follow-up on audits assigned by the QA Manager. Audits require interacting independently with all internal and external operational staff involved in the audited clinical research activities.Essential Responsibilities and DutiesThe Sr. QA Auditor is responsible for all or part of these areas but is not limited only to: Independently manages and performs compliance audits or as assigned on routine and complex audits. Process clinical investigator sites for clinical trials phase I-IV, including all related external/internal audit processes but not limited only to monitoring, data management (e.g., medical charts), filing/archiving, medical writing, study start-up, etc. Interface with the monitor at site monitoring visits as needed and conduct follow-up with CRSs to address all monitoring report issues. Work with the Regulatory department to accumulate accurate information to generate notes to file and timely submission to IRB. Prepare quality reviews for projects/studies, including coordination and management of inspection support, conduct of an investigation, and handling of outsourced activities performed by external consultants. Review study data, medical records, case report forms, monitoring letters, drug accountability, regulatory files, training personnel files (including CVs), and training records. May access unblinded information/data which requires professional secrecy to disclose any identity or medical information. Provide quality and continuous improvement support to study/project level by conducting follow-up on the progress status of assigned projects, establishing regular contact with operational teams, identifying and analyzing potential quality issues, assisting in monitoring the implementation of programs, participating in the analysis results of audits of assigned projects, and conducting a trend analysis for continuous improvement and proposing improvement/progress changes. Ensure adequate inspection preparedness, provide support to inspections, establish proper responses with effective CAPA, and timely follow-up on implementation with inspected sites/operational units. Assist in the design and participate in training on QA activities and other topics related to GCP, regulation, guidelines, etc. Participate in developing, revising, and implementing QA quality documents, working methodologies, tools, and systems. Support in coaching and mentoring junior staff or new hires.Minimum QualificationsKnowledge: Working knowledge of regulation, GCP, guidelines, and procedures pertaining to clinical research/trial. Working knowledge of audit techniques. Skill: Previous Clinical Quality Assurance or Clinical Trial (e.g., Monitoring or Trial Management) experience with progressive responsibilities working in Phase 1 clinical trials is required. Good analytical abilities and attention to detail. Previous work experience to propose pragmatic and innovative solutions to improve quality systems. Computer competency in Microsoft suite (Word, Outlook, Excel, and PowerPoint). Excellent written and oral communication skills.Ability: Ability to work independently and as a team. Ability to work with multiple deadlines and comprehend multiple clinical trials protocols in a fast-paced work environment. Ability to be detail oriented and well organized.Education/ Licenses/Certifications/Others: Bachelor's degree in life, medical, or related discipline or equivalent.Preferred Qualifications A Master's degree in life, medical, or related discipline or equivalent is preferred. Previous clinical research/trial experience in Central Nervous System is preferred.

Keywords: Jobot, Garden Grove , QA Auditor, Accounting, Auditing , Garden Grove, California

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