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Job Description
A biotech organization is seeking a Clinical Trial Specialist for a remote role in the United States. This position provides logistical support for one or more clinical trials and helps coordinate site start-up through close-out activities in alignment with SOPs and applicable regulations. About the
Opportunity:
Shift:
Day shift
Schedule:
Monday through
Friday Hours:
Standard business hours
Setting:
Remote (10% travel may be required)
Responsibilities:
Support the development, review, and maintenance of study documents, including site instructions, informed consent forms, lab manuals, pharmacy binders, reference manuals, and study plans Set up and maintain trackers, tools, dashboards, and reports to monitor study metrics and support trial operations Manage one or more small-scope vendors and support coordination of more complex vendors as needed Oversee assigned vendor contracts, including invoicing, purchase order monitoring, and forecasting with study lead oversight File study documents in the electronic Trial Master File, maintain essential documents lists, and coordinate TMF completeness reviews
Qualifications:
Bachelor's degree or equivalent experience At least 2 years of direct work experience in Clinical Research Understanding of study phases and how they apply to Clinical Development Ability to manage multiple tasks and deadlines while identifying issues and taking appropriate action Ability to work independently on problems of moderate scope and complexity Ability to build and maintain positive relationships with management and peers
Desired Skills:
Experience supporting site management activities Experience with electronic Trial Master File systems Experience with Vendor Management, Invoicing, Purchase Orders, and Forecasting Experience contributing to Study Management team meetings