13 ago
|
Syneos Health
|
España
13 ago
Syneos Health
España
CRA - Future Roles (Spain) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; Performs 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 processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic dat
📌 Clinical Trial Assistant (España)
🏢 Syneos Health
📍 España