Remote review of EDC (with or without source verification).  Where possible, performs sourcedata verification from web‐based sources. Writes, follows and resolves clinical queries and issues.    Remote review of drug accountability log. Conducts site management calls according to the monitoring plan.    Evaluates PI oversight (e.g. protocol adherence), subject safety and study processes in order toassess site’s ability to conduct study.    Provides refresher training, follow‐up on outstanding administrative needs (e.g.,outstanding/updated regulatory documents), assists with regulatory reviews, as requested,updates CTMS with site contact changes and maintains vendor tracker.    Reviews and escalates appropriately site key risk/performance/quality indicators (KRI, KPI, KQI[e.g., early termination and screen‐fail rates, average number of open findings, etc.]) , ad‐hocclinical listings review, tracking and trending of violations and deviations, ensuring visitsoccurred per the MP, site status, enrollment, CRF status and SAE follow‐up. Provides trial status tracking and progress update reports to CTM as required. Ensures study systems are updated per agreed study conventions (e.g., Clinical TrialManagement System – CTMS). Liaises with CRA to prompt collection of documents, review of data points, findings from EDCand file reviews, etc. Conducts remote investigations into site performance issues at the directive of the CTM.  Assists in ensuring audit ready files.  Contributes to company, client, and federal/local regulatoryrequirements/audit responses as needed.PPD is a leading global contract research organization providing comprehensiv

ICH-GCPDistribution of DSUR/BLL/SNLsProcessing of SUSAR/SAE/AESIsFull Service and Pass through service studies