Clinical Research Associate - In House
Theorem Clinical Research - Pennsylvania

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TRAINING AND EXPERIENCE
− 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

KEY SKILLS & BEHAVIORS
− 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:
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
− 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 - 2 years ago - save job
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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...