Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Clinical Trials Quality Specialist
Job Number: 82319
The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in the Department of Pediatrics - Division of Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, is seeking a Clinical Trials Quality Specialist to perform comprehensive audits and monitoring of Stanford Investigator-initiated clinical trials conducted under a IND or IDE and other high-risk protocols as necessary. The Clinical Trials Quality Specialist will perform extensive audits to determine compliance with IRB approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
The mission of the SCGT-CTO is to translate basic discoveries into innovative therapeutics to treat children with debilitating diseases for which there are no cures at present and the identification of curative therapies for such children will offer them new hope for health, improvement in their quality of life, and a reduction in medical costs compared to their present palliative, but not curative therapies.
Independently audit clinical research protocols to identify issues of protocol adherence, consent process and eligibility criteria and regulatory compliance. Preparations will include reviewing protocol documents in order to create an audit plan, selecting subject case files to be audited, and reviewing source documentation (which may include medical records). Collect data and backup documents to determine if the research team is complying with the protocol and regulatory requirements. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports
Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data
Lead the Root Cause Analysis and Corrective and Preventative Action plan process from development and through execution
Oversee audit-readiness plan for all clinical trials
Author audit reports, status reports, and other communications. Participate in the development and dissemination of written communications, such as guidelines and standard operating procedures, as well as educational presentation materials. Some reports and communications may be provided to department or program administration, in addition to investigators, with recommendations for reporting to the Stanford Institutional Review Board, external sponsors or FDA, when needed
* - Other duties may also be assigned
Professional certification is preferred, as a clinical research professional, auditor, quality or regulatory professional
Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.
At least 5 years in clinical research in industry or academia.
Proven auditing ability.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of related experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Excellent communication and organizational skills and superb attention to detail.
Experience with MS Office products and database applications required.
Excellent inter-personal skills and customer service focus is required.
Experience in clinical research management and oversight, including project management in a dynamic research setting.
Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
Experience in developing and implementing training/education.
Demonstrated ability to manage multiple projects and staff under varying time constraints.
Strong writing skills.
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
Occasionally sit, use a telephone or write by hand.
Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
May require occasional local and overnight travel.
Location: School of Medicine, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford University is an ...equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.