Spectrum, the Stanford Center for Clinical and Translational Research & Education, is an independent Stanford University center resulting from an NIH Clinical & Translational Science Award (CTSA). The core mission is to accelerate the translation of basic scientific discoveries into practical solutions that improve human health, through educational programs, research support, infrastructure streamlining, and innovation funding.
Spectrum is seeking a Clinical Trials Regulatory Specialist to work in the office of Clinical Research Quality (CRQ). Clinical Research Quality facilitates clinical research regulatory compliance by developing policies and best practices with the School of Medicine; tracking FDA, GCP, and ClincalTrials.gov compliance; educating and training researchers, both faculty, trainees, and staff; conducting quality reviews and assisting with corrective and preventive action when needed. CRQ collaborates with Stanford University and School of Medicine research compliance and internal audit offices.
The Clinical Trials Regulatory Specialist will work closely with the Regulatory Affairs Manager and the Clinical Trials Disclosure Manager (ClinicalTrials.gov program) to support the work in these programs, as well as with the Quality Improvement team to expand programs that support clinical research quality and compliance improvement initiatives.
Develop tools, templates, and Standard Operating Procedures in support of Stanford investigator-initiated Investigational New Drug (IND) and Investigational Device Exemption (IDE) research applications.
Facilitate compliant investigator submissions to ClinicalTrials.gov.
Review related regulatory applications and documents and facilitate correspondence and with regulatory agencies, including FDA and ClinicalTrials.gov.
Maintain expert knowledge of FDA Good Clinical Practice, Common Rule, and ClinicalTrials.gov regulations.
Provide regulatory support, guidance, and information to principal investigators and research staff.
Facilitate protocol development from a regulatory perspective, understanding which tools and templates are best for different types of research.
Contribute to the development of monitoring and auditing tools, programs and services for investigator-initiated research.
Facilitate external audits and inspections from industry sponsors and regulatory agencies.
Develop training and support materials such as Frequently Asked Questions, and prepare and deliver regulatory training in areas such as FDA submissions, inspection and audit readiness, ClincialTrials.gov, and related research quality areas.
Provide services and support to the research community, based on regulatory knowledge and understanding of Stanford policies and procedures.
Contribute regulatory knowledge to education and training initiatives.
Facilitate review and approval of controlled documents, and dissemination of new guidance to researchers.
Maintain and keep current the CRQ library of regulations and standards, and manage dissemination of changes in regulations to wider Stanford community.
Serve as liaison regarding CRQ initiatives with the IRB, offices of sponsored research and budgeting, and work closely with Stanford hospitals and other internal organizations or research groups to facilitate communication of regulatory knowledge.
Facilitate appropriate reporting to and from Clinical Research Units (CRUs).
May manage projects related to tracking institutional regulatory and compliance information, such as ClinicalTrials.gov compliance, IND and IDE annual reporting, corrective and preventive action (CAPA) status, and trending of audit findings.
May provide regulatory training to others in Spectrum or affiliated research groups.
Contribute to establishing and developing policies, Standard Operating Procedures (SOPs), regulatory memos and guidance for the conduct of clinical research. Ensure SOPs and controlled documents are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operations.
Ensure alignment with Stanford's research policies and procedures.
* - Other duties may also be assignedDESIRED QUALIFICATIONS:
Stanford University or Academic Medical Center experience with clinical research.
Previous experience writing standard operating procedure, ClinicalTrials.gov, and/or corrective and preventive action (CAPA) programs preferred.
Strong knowledge of FDA regulations and Good Clinical Practice (GCP).
Demonstrated ability to write clear instructions, standard operating procedures, training materials, and/or user documentation.
Clinical research, quality or regulatory professional certification preferred (ACRP, SOCRA, RAC, SQA).
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. WORKING CONDITIONS:
May require occasional local and overnight travel.
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
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.