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.