In-House Cra/Site Manager
CurrentSupport clinical research projects including, site and investigator recruitment, collecting investigator documentation, site management, and site monitoringPrepare and maintain status reports of activities at investigative sites throughout the entire clinical trial processQualify, initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.Assist and manage training of new Clinical Research Associates.Ensure subject safety through diligent monitoring of the site’s compliance with study protocols, ICH-GCP guidelines and all applicable regulations.Update, track and maintain study specific trial management tools/system.Complete site tracking reports and site contact documentation reports as required by study.Monitor Case Report Forms (CRF) for missing implausible data.Report, write narratives and follow-up on reported serious adverse experiences.Review submitted data and monitoring trip reports, recruitment plan and enrollment updates.Assist and manage project budget and investigator site budget as needed, attend project team meetings, investigator meetings, and communicate with clients.Generate and track investigational product shipments and storage.Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.Provide oversight of CROs, study vendors and laboratory vendors for adherence to deliverables, budget and timelines.
