Clinical Research Associate/Quality Oversight Assesor

The CRA Is Responsible For The Following:

Independent Assessment to Ensure the Integrity of Clinical Trial Data

Improved Efficiencies and Risk Mitigation through Co-Monitoring

Ability to write trip reports

Conducting site visits, including pre-study, initiation, monitoring and close-out;

Confirming adherence to all FDA, ICH-GCP and local regulations;

Ensuring the completion and collection of regulatory documents;

Performing data verification of source documents;

Ensuring implementation and compliance with FDA, ICH-GCP guidelines;

Participating in budget negotiation and follow-up where applicable;

Assisting with data validation and query resolution;

Conduct weekly site follow up


Qualifications

A minimum of 3 years of monitoring experience in various trials

Completion of a science-related Bachelor's degree

Excellent knowledge of medical terminology and clinical monitoring process

Experience with clinical trial information systems and various e/TMF systems

Ability to work USA hours. CENTRAL TIME ZONE