Clinical Research Associate (Mid-West USA)
Theorem Clinical Research - Pennsylvania

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TRAINING & 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 as a field monitor or in related clinical research field such as study coordination, in−house CRA, data
    management, or regulatory activities
  • Ability to travel as needed (approximately 65% to 70%)
  • Where applicable, fluency in English and local language
  • Availibility of a valid driver's license
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 matrix environment. A proven ability to take initiative and follow−up
Job Description:
SUMMARY
The primary function of a Clinical Research Associate I (CRA I) is to ensure the timely production of high quality clinical data, adhering to
the standards set by the Company/Sponsor in the Standard Operating Procedures for clinical studies and provide administrative support
to local country monitoring teams where applicable.

RESPONSIBILITES

  • Participates in identification of potential investigator sites
  • Conducts investigator recruitment and essential document collection. Reviews Case Report Forms for completeness and accuracy.
  • Conducts telephone monitoring visits
  • Conducts Pre−Study Monitoring visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they
    meet all study parameters and all FDA (if applicable) and GCP guidelines
  • Conducts Site Initiation visits. Reviews and explains study protocols with clinical investigators and clinical site staff. Serves as
    consultant to site personnel on all sponsor−related SOPs and regulatory requirements
  • Conducts Interim Monitoring visits. Reviews source documents, CRFs, regulatory documents, Informed Consents, Investigational
    Product, and clinical supply accountability. Ensures all Adverse Events have been documented and reported according to FDA
    regulations and sponsor protocols. Provides feedback and training to site personnel as needed
  • Conducts Close−Out visits. Retrieves and reconciles all study supplies. Archives study documentation and prepares the clinical site for
    any potential audits
  • Produces timely and accurate visit and status reports
  • Performs project tasks in other Company functional areas, as directed/as needed
  • Completes all other assignments given by management or as business needs require

Theorem Clinical Research - 17 months ago - save job - block
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...