Required:

• Bachelor's degree required, Master's degree preferred
• Minimum of 4+ years of experience in a clinical regulatory role
• Expert knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• In depth experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
• Demonstrated analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
• Demonstrated experience with FDA processes and procedures.
• Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
• Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
• Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
• Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
• Demonstrated analytical skills to address problems of high complexity.
• Ability to think creatively to develop solutions affecting the full team.