15 ago
|
Syneos Health
|
Madrid
15 ago
Syneos Health
Madrid
Description CRA I. Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Why Syneos Health• We are passionate about developing our people, through career development and progression; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job ResponsibilitiesPerforms site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and completeApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesUtilizes available hardware and software to support the effective conduct of the clinical project data review and captureVerifies site compliance with electronic data capture requirementsMay perform investigational product (IP) inventory, reconciliation
📌 Senior CRA (Madrid)
🏢 Syneos Health
📍 Madrid