Clinical Trials Regulatory Specialist 2
- Employer
- Stanford University
- Location
- School of Medicine, Stanford, California, United States
View more
- Institution Type
- Four-Year Institution
Job Details
- Create and maintain appropriate regulatory submissions to Stanford internal entities and the FDA.
- Serve as liaison for all Sponsor and/or regulatory agency regulatory activities.
- Perform detailed and comprehensive preparation of FDA regulatory documents for a wide range of studies of different complexities, therapeutic areas and phases, both drugs and devices.
- Help draft and review SCGT-CTO Guidelines and SOPs in accordance with international, federal, state, and local regulations.
- Work as part of the SCGT-CTO Regulatory Team. Specialists may also at times perform other duties such as training research teams in clinical research regulations, preparing for FDA audits, assisting with external audit preparation, and presenting at educational meetings.
- Professional certification is preferred, as a clinical research professional, auditor, quality or regulatory professional
- Stem Cell/BMT, Pediatrics, Gene Therapy, Oncology and /or hematology clinical trials experience
- Phase I/II Clinical Trials experience
- 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 attention to detail.
- 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.
- Schedule: Full-time
- Job Code: 4942
- Employee Status: Regular
- Grade: I
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 87520
Organization
Change the world. And yourself.
Stanford University has changed the world, over and over again.
We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.
At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment.
Stanford Facts at a Glance
Opened 1891
Student Enrollment
- Undergraduates: 6,980
- Graduates: 8,897
Campus
- 8,180 contiguous acres in six governmental jurisdictions
- Nearly 700 major buildings
- 97% of undergraduates live on campus
Research
- 5,300 externally sponsored projects
- $1.33 billion total budget
Faculty
- 2,043 faculty members
- 21 Nobel laureates are currently members of the Stanford community
- 5:1 student to faculty ratio
Stanford University is an Equal Employment Opportunity and Affirmative Action Employer and is committed to recruiting and hiring qualified women, minorities, protected veterans and persons with disabilities.
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