Clinical Trial Specialist
Location
United States
Posted
3 days ago
Salary
$88K - $108K / year
Seniority
Mid Level
Job Description
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
The Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more clinical trials. This position will work closely with cross-functional teams to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
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
2. Set up and maintain trackers, tools, dashboards, and reports study metrics to support the clinical trials
3. Manages one or more small-scope vendors; may support management of complex vendors
4. Oversee contracts of assigned vendors including invoicing, purchase order monitoring, and forecasting with study lead oversight
5. May be assigned site management responsibilities
6. 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
7. Contributes content to team meetings, including Study Management Team meetings
Requirements:
1. Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
2. Typically two years of direct work experience in Clinical Research
3. Understanding of study phases and general knowledge of how they apply to clinical development
4. Able to handle multiple tasks and deadlines, and identify issues and take appropriate actions
5. 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
6. Must have the ability to build and maintain positive relationships with management and peers
7. 10% travel may be required
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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