Job Description

Qualifications

Required:

  • Bachelor’s degree and/or equivalent combination of education and experience
  • Minimum of 4+ years of experience in a clinical research setting
  • Experience with Global Health programs/studies, including but not limited to the Lancet Commission on Cancer & Health Systems, Lancet Commission on Gender-Based Violence & Research Hub on Global Access to Palliative Care & Pain Relief
  • 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
  • Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions
  • 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 required
  • A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently required
  • Knowledge of and 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
  • Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner
  • Ability to handle confidential information with judgement and discretion
  • High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual required
  • Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc
  • Strong knowledge of and 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
  • Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws
  • Ability to think creatively to develop solutions affecting the full team
  • Experience with FDA processes and procedures
  • Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets

Preferred

  • Master’s Degree