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Clinical Trial Specialist

San Rafael, CA 94903

Posted: 03/22/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 546571 Is job remote?: No Country: United States

Job Description

The Clinical Trial Specialist (CTS) is a critical role, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities to help the clinical operations team support study timelines, quality and budget.
  • Motivation and Organization.  Driven to meet commitments and deliver high quality work on time.  Perform assigned tasks independently, prioritize tasks with help from manager and study lead, delegate tasks appropriately, and escalate issues as necessary.  Facilitate meetings within and across functions, anticipate future risks, needs and workloads, and set suitable timelines.  Demonstrate initiative in all aspects.  
  • Teamwork and Communication.  Work closely with other members of the clinical operations team and proactively offer support wherever needed.  Prepare training materials and educate members of the study team.  Collaborate with cross-functional teams, adapt to changing timelines with composure, and exhibit enthusiasm to supply on-time deliverables and help the team meet corporate timelines.
  • Vendor Management.  Contribute to vendor evaluation and selection.  Hold regular meetings with vendor project managers and oversee day-to-day operations to ensure vendor performance to statement of work, especially delivery of critical milestones.  Review statements of work and initiate change orders as needed.  Verify accuracy of vendor invoices and monthly accruals.  Escalate issues when necessary.
  • Data Integrity.  Perform data review of study subjects to ensure data accuracy, completeness, and compliance with clinical protocol.  Apply keen attention to detail to verify data quality, and issue queries and protocol deviations as warranted.  Work with cross-functional team to resolve issues.
  • Clinical Site Management.  Oversee multiple clinical sites as sponsor representative, partnering closely with CRO to serve as resource and confirm site compliance with protocol.  Perform initiation, monitor oversight, and other site visits to assess CRO quality of work and ensure site staff are properly trained and supported.  Review trip reports to ensure that clinical sites are receiving adequate monitoring. 
  • Compliance.  Monitor compliance with GCP, SOPs, and other applicable regulations during the execution of the study.  Ensure essential documents from clinical team, sites, and vendors are maintained in trial master file.
Education & Experience:
  • BA/BS or higher in nursing, life or health sciences is preferred.  Industry or relevant experience in lieu of education is considered.
  • 3 - 5 Years of Experience
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