For our Spanish operations we are looking for a Senior CRA We offer freelance and fixed-term contracts opportunities! Specific Job Duties: Thorough knowledge and application of project specific protocol Thorough knowledge of the local country laws applicable to clinical trials/ observational studies and ICH GCP. Consistently completes on site monitoring visits (including pre-study, initiation, interim monitoring and close-out visits ) in accordance with project specific timelines Consistently complete central monitoring call ( including pre-study, initiation, interim monitoring and close out call) in accordance with project specific timelines Consistently complete remote monitoring activities in accordance with project specific timelines Consistently completes travel scheduling in accordance with project specific and UBC guidelines Attends project team meetings, department meetings as required. Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections Consistently ensures follow-up of site issues and action items per UBC/sponsor timelines Consistently enters site visits/central monitoring calls, confirmation/follow-up letters and site monitoring reports into CTMS Consistently ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol, and enter them into CTMS Monitors within EDC data entry, if applicable, and assists sites with DCF resolution Consistently completes and maintain Regulatory Binder Consistently ensure accurate training of PI and site staff on study procedures and protocol Consistently submits expense reports within UBC timelines; consistently follows EU UBC Travel Guidelines Consistently completes UBC and/or Sponsor SOP review and documentation within requested timelines Consistently completes expense reports within UBC timelines; adheres to EU UBC Travel Guidelines Consistently completes sponsor specific training and documentation within requested timelines Assists PM and management team with co-monitoring. Assists management team by mentoring and co-monitoring of other CRAs Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training Assists management team by leading Sponsor local TCs, if required in local lenguage Accurate input into production of local language version of Patient Information Sheet and Informed Consent Review of translations according to UBC/sponsor SOPs Translation from/into local language into/from English for complete study specific communication Review and input into study protocol and case report form (CRF) review Consistently preparation, submission and tracking of Competent Authority, local ethics committee and other regulatory applications Consistently contract negotiation with hospitals and local R&D Departments Consistently review and confirm of visits/ processes to be paid to the site as per contract and communication to CSS/PAI/PAII (as delegate) for payment management: file, track, and log of site project invoicing Data Management Department data query resolution Check of EDC tools and if required translation into local language Administrative and logistical support to the Project Manager of (international) clinical trials in order to coordinate all study-related activities. Maintain TMF (eTMF, web study portal, M drive or paper in accordance with project specific procedures) and track collection of essential documents Organize logistics of international study meetings Translation of all types of Clinical Trial related documents from/into local language into/from English Study feasibility assessments Consistently complete and maintain Clinical Trial Management System (UBC Track, IMPACT or other) according to project specific requirements Consistently complete all other project specific tracking tools Consistently escalate issues found at the site in timely manner according to project specific requirements Requirements: Bachelor’s degree – Life Science preferred, or equivalent years of industry and monitoring experience (according to the local legislation) Minimum of >24 months active monitoring (with certification of previous experience, if requested according to the local legislation) At least one Training Education File form signed by the LM ( on site monitoring visit/ central monitoring call) AIMS training to mentoring on site co-monitoring visits/ central monitoring calls Thorough knowledge of medical terminology Good written and verbal communication skills Consistently meets or exceeds metrics for quality trip reports and letters Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable) Thorough knowledge of ICH-GCP and UBC SOPs Up to 80% travel Please apply vi**********
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