Job Description
Job Overview
Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.
Essential Functions
• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
• Review all reported Adverse Events (AEs) , Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed info...