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DESIRED QUALIFICATIONS:
Desired qualifications include a basic understanding of human subjects research regulations, or extensive experience with clinical research in general. Previous experience with CAR-T cells or cellular therapy and/or writing protocols or other scientific writing is desirable. Must be able to work occasionally on site at Stanford’s Palo Alto campus.
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:
None required. RAPS or other regulatory affairs coursework preferred.
PHYSICAL REQUIREMENTS*:
- Constantly perform desk-based computer tasks.
- Frequently stand/walk, sitting, grasp lightly/fine manipulation.
- Occasionally use a telephone.
- Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
* - 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:
Remote and hybrid office work. May require occasional local and overnight travel.
WORK STANDARDS:
- 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.
The expected pay range for this position is $102,000 to $118,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.