Regulatory Affairs Coordinator

Job Description

Insight Global is looking for a Regulatory Coordinator under the supervision of the Sr. Regulatory Manager participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI’s, and research clinical staff in the Lewis Katz School of Medicine’s Thoracic Medicine & Surgery department.

Required Skills & Experience

• Bachelor’s degree and at least 3 years of experience in research and/or regulatory compliance in a research or clinical setting. An equivalent combination of education and experience may be considered.
• 3 years of regulatory compliance submission experience (IRB, ICBF, WCG)
• Excellent interpersonal and communications skills, including the ability to interact with as diverse constituent population
• Strong analytical and problem-solving skills
• Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously
• Ability to travel, including by air or by car to attend study training meetings as required by study project
• Demonstrated computer skills, and proficiency with MS Office Suite software programs.
• Excellent written and verbal communication skills
• Patient facing experience
• Ability to travel to off-site locations that may not be accessible via public transportation Ability to work evenings/weekends hours as needed