Clinical Trials Regulatory Specialist 1

DESIRED QUALIFICATIONS:
•    Experience submitting regulatory documents to the NCI CIRB, or other central Institutional Review Board.
•    Ability to multi-task, manage, and report on up to 5 new studies and/or 7 amendments/revisions at one time.
•    Knowledge of oncology and clinical research conduct desired.
•    Experience developing and delivering training.
•    Certification through a professional organization such as RAPS or SOCRA preferred.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and three years of related experience or a combination of relevant education and experience. 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
•    Excellent communication 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 trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB. 
•    Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. 
•    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.

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.