Clinical Trials Regulatory and Quality Specialist

DESIRED QUALIFICATIONS:

• Experience with Investigator Initiated (IIT) Clincial Trials
• Experience with study monitoring of data or regulatory records
• Experience developing processes, policies or Standard Operating Procedures
• Certification in clincial research (such as ACRP, SOCRA, Stanford CROP or other programs)

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.

CERTIFICATIONS & LICENSES:

None

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.