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.