Required:

·       Bachelor’s Degree in related area and/or equivalent combination of education and experience. Advanced degree preferred

·       Minimum of 4+ years of experience in a clinical research setting

·       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 proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. 

·       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.

·       Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.

·       High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual.

·       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.

·       Experience with FDA processes and procedures.

·       Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets.