Clinical Trials Regulatory Specialist 2
The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in Department of Pediatrics, Stanford University School of Medicine, is seeking a Clinical Trials Regulatory Specialist level 2 (CTRS2). This role will be responsible for the execution of regulatory submissions to Stanford Internal Entities and the FDA, and will aid in the regulatory oversight of phase I/II clinical research studies. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials involving cellular products and gene therapies. 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.
- 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.
* - Other duties may also be assigned
- 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.
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.
CERTIFICATIONS & LICENSES:
- 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
- Schedule: Full-time
- Job Code: 4942
- Employee Status: Regular
- Grade: I
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 87520