Clinical Trial Specialist

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare diseases, as a Clinical Trial Specialist (CTS). The CTS will provide logistical support for clinical trials, collaborating with cross-functional teams to ensure adherence to SOPs and regulations. Responsibilities include developing and maintaining study documents, managing vendors and contracts, overseeing site management, and contributing to team meetings. The ideal candidate will possess a Bachelor's degree, two years of clinical research experience, and a strong understanding of clinical development. The position offers a competitive salary, annual bonus and equity incentives, and a comprehensive benefits package including generous vacation time, volunteer days, long-term incentives, employee wellbeing benefits, and professional development opportunities. The work model is remote with occasional travel. Ultragenyx is committed to creating a supportive and inclusive work environment.

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

Responsibilities

• 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

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