Clinical Trials Quality Specialist

🔍 School of Medicine, Stanford, California, United States

📁: Research

📅   : Mar 11, 2019 Post Date

📅   : 82319 Requisition #

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DESIRED QUALIFICATIONS:
• 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 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.

PHYSICAL REQUIREMENTS*:

• 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.

Additional Information