
Clinical Research Associate
The Clinical Research Associate will perform all types of site visits including Site Selection, Initiation, Monitoring, and Close-out, as well as drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols. Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results. Perform review of Site Investigator File, source documents verification, retrieve Case Report Forms (CRFs) and performed query resolution in a timely manner, and follow the appropriate filing of documents in Investigator Site File and In-house Investigator Site File.
Prefer a minimum of 2 years monitoring experience
Thorough Knowledge of FDA regulations and ICH/GCP guidelines.
Documentation
Time Management
MS Excel
MS Word
MS PowerPoint
Multitasking
Process Improvement
Verbal communication
Detail Oriented
written communication
Results driven
According to JobzMall, the average salary range for a Clinical Research Associate in 19495 Biscayne Blvd, Miami, FL 33180, USA is $52,000 to $70,000 per year. Salaries may also vary depending on the experience and qualifications of the applicant.
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Biorasi is a contract research organization widely recognized for delivering success in complex clinical trials. This is possible through TALOS™, an innovative operating model that unifies systems and teams with a powerful project management methodology to ensure high quality delivery.

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