Clinical Research Associate - In House
Theorem Clinical Research - King of Prussia, PA

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Bachelor's degree from an accredited institution of higher education or RN certificate required. Degree in Life Sciences preferred −
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 −
Ability to travel, as needed (approximately 10%) −
Fluent in English

Demonstrated knowledge of clinical monitoring and applicable regulatory requirements −
Attention to detail and a methodical approach to work −
Good communication skills with ability to relay pertinent information to site personnel and study team −
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 −
Strong organizational skills. Ability to work effectively within an office environment. A proven ability to take initiative and follow−up
independently −
Computer literate; Microsoft Office skills including Word, Excel, and Outlook

Job Description:
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).

Supports study start−up phase including feasibilities, investigator recruitment, essential document collection and investigator meetings −
Prepares, maintains and conducts regular QC of PMF for applicable projects −
Provides systems support for project team (IVRS, eDC, laboratory database, Theorem systems, etc.) −
Corresponds with study sites including telephone monitoring visits and routine site correspondence. May act as primary site contact
during study −
Reviews study plans with investigative site staff to ensure they meet all study and regulatory requirements −
Reviews Case Report Forms remotely for completeness and accuracy. Resolves data queries with sites −
Assists project team with general project coordination including coordination of study supplies, assistance with meeting minutes,
project trackers, contact lists, newsletters and status reports −
Supports CRA with visit scheduling, logistics, supplies and resolution of site action items −
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 −
Attend internal and external study specific meetings; including potential kick−off meetings, bid defenses and trainings −
Assist with training and mentoring when applicable −
Completes all other assignments given by management or as business needs require

Theorem Clinical Research - 14 months ago - save job - block
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About this company
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Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...