Ultragenyx

Clinical Trial Specialist

Ultragenyx

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $88,000 - $108,700 per year

About the role

  • Supports development, review, and maintenance of study documents such as site instructions, site specific Informed Consent Forms, Lab Manual, Pharmacy Binder, Study Reference Manual, study plans, etc
  • Set up and maintain trackers, tools, dashboards, and reports study metrics to support the clinical trials
  • Manages one or more small-scope vendors; may support management of complex vendors
  • Oversee contracts of assigned vendors including invoicing, purchase order monitoring, and forecasting with study lead oversight
  • May be assigned site management responsibilities
  • Files study documents in the electronic Trial Master File (TMF), maintain essential documents lists, participation and coordination of TMF completeness reviews, and may serve as the main study contact for Records Management
  • Contributes content to team meetings, including Study Management Team meetings

Requirements

  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
  • Typically two years of direct work experience in Clinical Research
  • Understanding of study phases and general knowledge of how they apply to clinical development
  • Able to handle multiple tasks and deadlines, and identify issues and take appropriate actions
  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
  • Must have the ability to build and maintain positive relationships with management and peers
  • 10% travel may be required
Benefits
  • Generous vacation time and public holidays observed by the company
  • Volunteer days
  • Long term incentive and Employee stock purchase plans or equivalent offerings
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchstudy document managementtracker setupreportingvendor managementcontract oversightinvoicingpurchase order monitoringelectronic Trial Master File (TMF)data analysis
Soft Skills
self-motivatingproblem-solvingrelationship buildingtime managementcommunicationteam collaborationtask prioritizationadaptabilityattention to detailorganizational skills