TRAINING AND EXPERIENCE
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Bachelor's degree from an accredited institution of higher education or RN certificate required. Degree in Life Sciences preferred
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At least 1 year of experience in related clinical research field such as study coordination, in−house CRA, data management, or
regulatory activities. Medical device experience is preferred
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Ability to travel, as needed (approximately 10%)
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Fluent in English
KEY SKILLS & BEHAVIORS
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Demonstrated knowledge of clinical monitoring and applicable regulatory requirements
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Attention to detail and a methodical approach to work
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Good communication skills with ability to relay pertinent information to site personnel and study team
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Strong team skills with ability to work effectively with Company Clinical Monitoring Managers, Lead CRAs, Project Managers and
Project Directors as well as site personnel
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Strong organizational skills. Ability to work effectively within an office environment. A proven ability to take initiative and follow−up
independently
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Computer literate; Microsoft Office skills including Word, Excel, and Outlook
Job Description:
Summary
The primary function of an In−House Clinical Research Associate is to ensure the timely production of high quality clinical data, adhering
to the standards set by Theorem Clinical Research/Sponsor in the Standard Operating Procedures for clinical studies. To be responsible
for coordinating and delivering administrative support to the allocated Project Team(s).
JOB RESPONSIBILITIES
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Supports study start−up phase including feasibilities, investigator recruitment, essential document collection and investigator meetings
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Prepares, maintains and conducts regular QC of PMF for applicable projects
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Provides systems support for project team (IVRS, eDC, laboratory database, Theorem systems, etc.)
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Corresponds with study sites including telephone monitoring visits and routine site correspondence. May act as primary site contact
during study
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Reviews study plans with investigative site staff to ensure they meet all study and regulatory requirements
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Reviews Case Report Forms remotely for completeness and accuracy. Resolves data queries with sites
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Assists project team with general project coordination including coordination of study supplies, assistance with meeting minutes,
project trackers, contact lists, newsletters and status reports
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Supports CRA with visit scheduling, logistics, supplies and resolution of site action items
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Ensure that all relevant members of the internal team and sponsor are informed of progress and status of assigned projects with
recommendations for any anticipated outstanding issues
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Attend internal and external study specific meetings; including potential kick−off meetings, bid defenses and trainings
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Assist with training and mentoring when applicable
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Completes all other assignments given by management or as business needs require
Theorem Clinical Research - 4 months ago
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