Regulatory Coordinator

Job Description Insight Global is looking for an 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. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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• 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
• Familiarity with the medical and pharmaceutical industries, and related terminology and practices
• Knowledge of FDA regulations and their practical implementation
• CPR
• IATA training
• Human Subjects training Research Certification