UBC - Senior Clinical Research Associate, Research & Clinical Services (Spain) FTC, Madrid
Entry (0-2 years), Middle (2-5 years), Senior (5-10 years), Executive (>10 years)
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##### Schedule: Full-time ##### Job ID:R **Brief Description:** The Senior Clinical Research Associate (SCRA) is responsible for monitoring in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs. This is a home-based 12 month fixed-term contract. **Specific Job Duties:** + 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 completes on site monitoring in accordance with project specific timelines + Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS + Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings + Completes Regulatory Binder and Investigational Product reconciliation + Maintains regular contact with assigned sites per study requirements + Consistently completes sponsor specific training and documentation within requested timelines + Ensures follow-up of site issues and action items per UBC/sponsor timelines + Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol **Requirements:** + Bachelor's degree required + Minimum of 24 months active monitoring experience + Thorough knowledge of medical terminology + Good written and verbal communication skills + Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable) + Thorough knowledge of ICH, GCP, CFR and SOPs + Up to 50% travel **ABOUT UBC Europe** United BioSource Corporation (UBC) is the leading provider of integrated development and commercial support solutions that deliver evidence of safe use, while optimizing access to mediation and care. UBC leverages our specialty pharmacy therapy expertise and contracts for specialty pharmacy and specialty distribution services. UBC's services include reimbursement, patient assistance and alternate funding programs, channel optimization through specialty pharmacy, specialty distribution and 3PL services, Customized clinical adherence and commercialization strategies powered by Express Scripts data.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.