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
