Description:
The Research Assistant helps the Research Coordinator plan, organize, and conduct research in scientific, cultural, historical, or artistic field for use in own work or in project of sponsoring institution by performing the following duties.
Essential Job Functions/Competencies
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Assist Research Coordinator in conducting all clinical studies according to FDA regulations and guidelines.
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Obtains detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities correctly and completely.
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Performs searches using The Urology Group Software Systems (EMR, Accounting, etc.) to aid study coordinator in recruitment for clinical trials
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Assists Research Coordinator in calling potential subjects for trial participation
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Assists Research Coordinator in scheduling subject visits and procedures to meet protocol requirements.
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Assists Research Coordinator in reporting all adverse events to the sponsor and IRB in compliance with FDA regulations and sponsor requirements.
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Assists Research Coordinator as necessary in reporting all serious adverse events to the sponsor within 24 hours and notifies the IRB promptly.
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Assists Research Coordinator in maintaining all study related documents within regulatory binder in timely manner for each trial.
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Assists Research Coordinator in entering data collected during study visit into either paper case report form book or electronic data capture system
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Maintains confidentiality of all patient information and disseminates it to others on a need-to-know basis.
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Performs other duties as assigned.
Requirements:
Certifications, Licensures or Registry Requirements
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Graduate of an accredited school in a health-care related discipline or equivalent; or two to three years related experience and/or training; or equivalent combination of education and experience
Knowledge/Skills/Abilities
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Basic computer skills
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Attention to detail
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Exceptional interpersonal skills
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Excellent organization skills
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Ability to prioritize a variety of tasks
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Flexibility with hours
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Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations
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Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
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Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
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Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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Possess basic computer skills and have knowledge of Microsoft Word and Excel.
Educational Requirements
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Bachelor’s degree in a health-care related discipline or equivalent
Experience Requirement
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1-3- preferred, but not required, can train.