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 Manager to work with Clinical Research Quality (CRQ) as a Regulatory Affairs Manager. 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 Regulatory Affairs Manager would be responsible for establishing a regulatory affairs consulting program for faculty researchers, facilitating regulatory compliance of sponsor-investigator clinical research within the School of Medicine, and representing the university with external regulatory agencies, both domestic and international. Duties include:
Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects. Establish standard processes for IND and IDE submissions to FDA. Create templates for initial submissions, amendments, annual reports, and adverse event reporting. Support faculty efforts and ensure effective agency communications.
Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics. Understand the portfolio of Stanford faculty-held INDs and IDEs. Manage integration of regulatory information with existing systems (Oncore, eProtocol) and establish processes for keeping data current and complete; generate reports as required for School of Medicine leadership or departments, centers, institutes.
Develop methods for tracking compliance with IND and IDE sponsor responsibilities. Align with existing Stanford clinical trial programs and regulatory staff to support faculty with sponsor responsibilities. Interface with manufacturing facilities and laboratories at Stanford to identify areas for collaboration.
Lead efforts, authorize and manage submissions to internal and external agencies. Provide final review and approval for submissions and reports. Provide guidance and consultation for IND and IDE submissions to FDA. Recommend strategies for process flow improvements between university and school offices.
No current supervisory responsibilities, but could develop as Stanford Medicine's portfolio of clinical trials grows.
Oversee, develop and facilitate educational and compliance training programs. Collaborate with Spectrum Education and other institutional offices to deliver regulatory training to faculty and staff.
Evaluate and analyze the impact on new or changed regulations and determine how to implement within Stanford Medicine. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance with FDA and GCO, as well as the Common Rule.
Serve as a regulatory point of contact during external audits. May act on behalf of Senior Management in regard to interactions with regulatory agencies. With CRQ Quality Auditor(s), develop a smoothly functioning process to prepare for and consult during FDA inspections.
Represent department or institute in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the National Institutes of Health, including NIH GCP monitoring, and industry sponsor auditors.
Interact and advise senior management on clinical trials regulatory processes or decisions. Support the CRQ Director and other Spectrum and SOM/University leadership as needed.
* - Other duties may also be assigned. DESIRED QUALIFICATIONS:
Stanford University or Academic Medical Center regulatory affairs experience - prefer 2 years or more.
Previous experience with IND and/or IDE submissions to FDA for clinical research - prefer 1 year or more.
Strong knowledge of FDA regulations for clinical research and Good Clinical Practice (GCP).
Demonstrated experience with FDA inspections for clinical research.
Clinical research, quality or regulatory professional certification preferred (e.g., RAPS, ACRP, SOCRA, ASQ).
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Experience in clinical research management and oversight, including project management in a dynamic research setting.
Experience in a lead role and interactions with federal agencies, i.e. FDA.
Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice.
Knowledge of International Conference on Harmonization (ICH) standards.
Experience in developing and implementing multifaceted projects.
Excellent communication and organizational skills and superb attention to detail.
Experience with MS Office products and database applications required.
Strong written and verbal 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.