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UBC - Senior Clinical Research Associate (home-based) FTC - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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UBC - Senior Clinical Research Associate (home-based) FTC

Nr ref.: /JOBS.pl

  • Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.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 fixed-term contract, home-based in the Netherlands. 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 correctionsConsistently completes on site monitoring in accordance with project specific timelinesEnters site visits, confirmation/follow-up letters and site monitoring reports into CTMSAttends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetingsCompletes Regulatory Binder and Investigational Product reconciliationMaintains regular contact with assigned sites per study requirementsConsistently completes sponsor specific training and documentation within requested timelinesEnsures follow-up of site issues and action items per UBC/sponsor timelinesEnsures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol Requirements:Bachelor's degree requiredMinimum of 24 months active monitoring experienceThorough knowledge of medical terminologyGood written and verbal communication skillsAbility to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable)Thorough knowledge of ICH, GCP, CFR and SOPsUp to 50% travel NO AGENCIES PLEASE


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