Clinical Research Associate

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POST DATE 8/31/2016
END DATE 10/23/2016

Technical Resources International Inc. Bethesda, MD

Company
Technical Resources International Inc.
Job Classification
Full Time
Company Ref #
352815
AJE Ref #
576029874
Location
Bethesda, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Provides site monitoring and site management services for sponsored clinical trials.
Conducts on-site pre-study/qualification, initiation, routine, and close-out monitoring visits, following corporate and/or sponsor Standard Operating Procedures (SOPs) and other requirements.
Performs on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review. Prepares visit reports and provides assistance to site staff in resolving deficiencies.
Develops and demonstrates understanding of assigned therapeutic areas and applies knowledge to study and project-related issues.
Educates and trains site and study staff in study conduct, including compliance with FDA and ICH/GCP guidelines.
Collects and reviews regulatory documents in compliance with guidelines and standards.
Assists in Protocol, Informed Consent, and CRF design and review.
Appropriately resolves issues related to site monitoring and management with guidance from the Project Manager.
Decisions are made independently and with some supervision from Line or Project Manager.